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Female cancer researchers receive less funding than male counterparts
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
Female cancer researchers receive significantly less funding than their male counterparts in terms of total investment, number of awards, and mean and median funding, according to an analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
In an analysis of 4,186 awards totaling 2.33 billion pounds, 2,890 grants (69%) with a total value of 1.82 billion pounds (78%) were awarded to male primary investigators (PIs), compared with just 1,296 grants (31%) with a total value of 512 million pounds(22%) for female PIs, investigators reported in BMJ Open.
Investigators studied openly accessible information on funding awards from public and philanthropic sources including the Medical Research Council, Department of Health, Biotechnology and Biological Sciences Research Council, Engineering and Physical Science Research Council, Wellcome Trust, European Commission, and nine members of the Association of Medical Research Charities. Awards were excluded if they were not relevant to oncology, led by a non-U.K. institution, and/or not considered a research and development activity, wrote Charlie D. Zhou, MD, of the Royal Free NHS Foundation Trust Department of Nuclear Medicine in London, and coauthors.
Median grant value was greater for men (252,647 pounds; interquartile range, 127,343-553,560 pounds) than for women (198,485 pounds; IQR, 99,317-382,650 pounds) (P less than .001). Mean grant value was also greater for men (630,324 pounds; standard deviation, 1,662,559 pounds) than for women (394,730 pounds; SD, 666,574 pounds), Dr. Zhou and colleagues reported.
Large funding discrepancies were seen for sex-specific cancer research. For instance, males received 13.8, 3.5, and 2.0 times the investment of their female counterparts in total, mean, and median prostate cancer funding, respectively. Likewise, men received 9.9, 6.6, and 2.9 times the funding of women PIs in total, mean, and median funding, respectively, for cervical cancer research. This pattern was true for ovarian cancer and breast cancer research, as well.
Men also received significantly greater median funding at all points of the research and development pipeline. For preclinical, phase 1, 2, or 3 clinical trials; and public health, men received 20%, 90%, and 50% more, respectively (P less than .001); for product development and cross-disciplinary research, the difference was 50% and 20%, respectively (P less than .01).
The results of the analysis demonstrate that “female PIs clearly and consistently receive less funding than their male counterparts,” the authors wrote. Although the study results are descriptive in nature and do not identify the underlying mechanisms for these discrepancies, they “demonstrate substantial gender imbalances in cancer research investment.
“We would strongly urge policy makers, funders and the academic and scientific community to investigate the factors leading to our observed differences and seek to ensure that women are appropriately supported in scientific endeavor,” they concluded.
No disclosures or conflicts of interest were reported.
SOURCE: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
FROM BMJ OPEN
Key clinical point: Female cancer researchers receive significantly less funding than their male counterparts.
Major finding: Of 4,186 awards, 2,890 grants (69%) were awarded to male primary investigators (PIs), compared with 1,296 grants (31%) for female PIs.
Study details: An analysis of data on public and philanthropic cancer research funding awarded to U.K. institutions between 2000 and 2013.
Disclosures: No disclosures or conflicts of interest were reported.
Source: Zhou CD et al. BMJ Open. 2018 Apr 30. doi: 10.1136/bmjopen-2017-018625.
2017 notches up some landmark approvals
With advances in the understanding of cellular pathways, molecular genetics, and immunology, new drugs for cancer are being released at an increasing rate. A variety of novel agents have recently become available for use, generating excitement for patients and oncologists. Keeping track of all of these new agents is increasingly challenging. This brief review will summarize some of the newest drugs, their indications, and benefits (see related article).
Therapies by tumor
Breast cancer
CDK4/6 inhibitors. The CDK4/6 inhibitor palbociclib was approved in 2015 for the treatment of estrogen-positive, HER2-negative advanced breast cancer, and this year, two more drugs in this class – ribociclib and abemaciclib – were approved for the treatment of hormone receptor–positive breast cancer.
Ribociclib (Kisqali) 600 mg daily (3 weeks on, 1 week off) is approved for use in combination with an aromatase inhibitor. In the study on which the approval was based, there was a response rate of 53% for patients in the study group, compared with 37% for those who received aromatase inhibitor alone (progression-free survival (PFS), not reached vs 14.7 months for single-agent aromatase inhibitor).1 The occurrence of neutropenia seemed to be similar to that in patients receiving palbociclib. However, unlike with palbociclib, ribociclib requires ECG monitoring for QTc prolongation as well as monitoring of liver function tests.
Abemaciclib (Verzenio) has been approved in combination with fulvestrant as well as a monotherapy.2 PFS was 16.4 months for abemaciclib (150 mg bid in combination with fulvestrant), compared with 9.3 months for fulvestrant alone, with corresponding response rates of 48% and 21%. As monotherapy, abemaciclib 200 mg bid had a response rate of 20% with a duration of response of 8.6 months.
Tyrosine kinase inhibitors. The tyrosine kinase inhibitor neratinib (Nerlynx) was approved for extended adjuvant treatment of HER2-positive breast cancer after 1 year of adjuvant trastuzumab.3 Given at 240 mg (6 tablets) daily for a year, compared with a no-treatment control arm, it demonstrated an improvement in invasive disease-free survival (DFS) at 2 years from 91.9% to 94.2%, with no difference in overall survival yet noted. It is associated with diarrhea and also requires hepatic function monitoring.
Acute myelogenous leukemia
Multiple new agents were recently approved for use in acute myelogenous leukemia (AML), after decades of slow advance in new drug development.
Midostaurin (Rydapt) is an FLT3 inhibitor approved for use in combination with daunorubicin and Ara-C (cytosine arabinoside) for newly diagnosed AML with FLT3 mutations, which occur in about 30% of AML patients.4 It is given orally on days 8-21 at 50 mg bid with induction and consolidation.
In the study on which the approval was based, there was a 10% improvement in overall survival for this subset of AML patients who have a typically a worse prognosis. Event-free survival in patients in the study group was 8.2 months, compared with 3 months in the control arm patients, who did not receive the agent. The drug was also approved for aggressive systemic mastocytosis.
Enasidenib (Idhifa) has been approved for AML with an IDH2 mutation in the refractory/relapsed settings.5IDH2 mutations are present in about 20% of patients with AML. Given orally at 100 mg daily as a single agent, enasidenib was associated with a 19% complete remission rate. Patients need to be monitored for differentiation syndrome, somewhat similar to what is seen with ATRA with acute promyelocytic leukemia.
Liposomal daunorubicin and cytarabine (Vyxeos) was approved for newly diagnosed therapy- or myelodysplasia-related AML.6 This novel liposomal formulation combines two standard agents and is given intravenously on days 1, 3 and 5 over 90 minutes as daunorubicin 44 mg/m2 and cytarabine 100 mg/ m2. (For a second induction and in lower dose on consolidation cycles, it is given only on days 1 and 3). The liposomal formulation achieved a superior complete response rate compared with the standard 7+3 daunorubicin plus cytarabine regimen (38% vs 26%, respectively) and longer overall survival (9.6 versus 5.9 months) in these generally poor prognosis subsets.
Gemtuzumab ozogamicin (Mylotarg) was initially approved in 2000 but withdrawn from use in 2010 after trials failed to confirm benefit and demonstrated safety concerns. It has now been re-released in a lower dose and schedule from its original label.7 This immunoconjugate of an anti-CD33 bound to calicheamicin is approved for CD33-positive AML. Given at 3 mg/m2 on days 1, 4, and 7 in combination with standard daunorubicin–cytarabine induction chemotherapy, it improved event-free survival from 9.5 to 17.3 months. When administered as a single agent (6 mg/m2 on day 1 and 3 mg/m2 on day 8) in patients who were unable or unwilling to tolerate standard chemotherapy, it improved overall survival (4.9 months versus 3.6 months for best supportive care). As a single agent in relapsed AML, given at 3 mg/m2 days 1, 4, and 7 and followed by cytarabine consolidation, it was associated with a 26% complete response rate, with a median relapse-free survival of 11.6 months.
Ovarian/fallopian tube cancers
PARP inhibitors. For patients with ovarian/fallopian tube cancer, there are new indications and agents for PARP inhibition, including for patients with BRCA mutations (both somatic and germline) and those without BRCA mutations.
Olaparib (Lynparza) was previously approved only in a fourth-line setting for germline BRCA-mutated patients with advanced ovarian cancer, with a response rate of 34% with a median duration of 7.9 months. Given at 300 mg orally bid, it is now approved for use in maintenance in recurrence after response to platinum-based chemotherapy after 2 or more lines of therapy regardless of BRCA status. In this setting, progression-free survival increased to 8.4 months, compared with 4.8 months for placebo.8
Rubicarib (Rubraca) is approved for BRCA-mutated patients (either germline or somatic) with advanced ovarian cancer after two or more lines of chemotherapy.9 At 600 mg orally bid, results from phase 2 trials noted a 54% response rate, with a median duration of 9.2 months.
Niraparib (Zejula) is approved for use in maintenance in recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers after platinum-based chemotherapy.10 In patients with germline BRCA mutations, niraparib at 300 mg orally daily resulted in a PFS of 21 months, compared with 5.5 months with placebo; PFS in patients with nongermline BRCA mutations was 9.3 versus 3.9 months, respectively.
Non-small cell lung cancer with EML-4 alk translocation
Crizotinib (Xalkori) has been the mainstay for treatment of for EML4-alk translocated non-small cell lung cancer. However, alectinib (Alcensa), previously for predominantly second-line use, seems more active than crizotinib in the first-line setting, particularly in the treatment and prevention of CNS metastases.
In addition, brigantinib (Alunbrig) has been approved for patients who are intolerant/refractory to crizotinib.11 At 90 mg once daily for 7 days, then escalating to 180 mg daily, it was noted to have a 50% response rate in crizotinib failures, including in the CNS.
Ceritinib (Zykadia) was approved at 750 mg once daily for EML4 alk positive NSCLC.12 In first line it had a response rate of 73% (versus 27% for chemotherapy) with a remission duration of 23.9 months (versus 11.1 months for chemotherapy).
Therapies by drug class
PD-1/PD-L1 antibodies
Anti-PD-1 antibodies nivolumab (Opdivo) and pembrolizumab (Keytruda) are widely used for a range of tumor types. Newer approvals for pembrolizumab are for adenocarcinoma of the stomach/gastro-esophageal junction with at least 1% PD-L1 expression, and in any tumor demonstrated to be MSI-high. Newer indications for nivolumab are for bladder cancer, MSI-high colon cancer, and for hepatoma previously treated with sorafenib. The anti-PD-L1 antibody atezolizumab (Tencentriq) is now approved for platinum-resistant metastatic lung cancer, in addition to platinum-ineligible and platinum-resistant urothelial cancer.
Avelumab (Bavencio) is an anti-PD-L1 approved for both Merkel cell and previously treated urothelial cancers at a dose of 10 mg/kg every 2 weeks.13 It demonstrated a 33% response rate for Merkel cell and a 16% response rate for urothelial cancer.
Durvalumab (Imfinzi) is another anti PD-L1 antibody approved at 10 mg/kg every 2 weeks for previously treated urothelial cancer with a 17% response rate (RR: PD-L1 high, 26%; low, 4%).14
PI3K kinase inhibitors
Copanlisib (Aliqopa) is a PI3K inhibitor approved for relapsed follicular lymphoma in patients who have progressed after two previous lines of therapy.15 It is a 60-mg, 1-hour infusion given on days 1, 8, and 15 every 28 days. In a phase 2 tria
BTK inhibitors
Acalabruitnib (Calquence) is approved for adults with previously treated mantle cell lymphoma. In a phase 2 trial at 100 mg orally bid, it achieved an 80% overall and 40% complete response rate.16 These response rates are higher than were seen for ibrutinib in its original phase 2 trial. The spectrum of toxicities seems similar to ibruitinib and includes bleeding, cytopenias, infection, and atrial fibrillation.
CD19 CAR-T cells
Perhaps the most exciting and novel new agents are genetically engineered autologous T cells. Tisagenlecleucel (Kymriah), a chimeric antigen receptor T cell (CART) that targets CD19 is approved for refractory B cell precursor acute lymphoblastic leukemia (in patients under 25 years) where the complete response rate was 83% (including patients with incomplete blood count recovery).17
Axicabtagene ciloleucel (aci-cel; Yescarta), also CD19-directed CART, is approved for adults with relapsed or refractory non-Hodgkin lymphoma after two lines of previous therapy (specifically large-cell lymphoma, primary mediastinal large B-cell lymphoma, and transformed follicular lymphoma). Response rate was 72% (complete, 51%; partial, 21%), with a median duration of response of 9.2 months.18
1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748.
2. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646.
3. Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17(3):367-377.
4. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454-464.
5. Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731.
6. Lancet JE, Rizzieri D, Schiller GJ, et al. Overall survival (OS) with CPX-351 versus 7+3 in older adults with newly diagnosed, therapy-related acute myeloid leukemia (tAML): subgroup analysis of a phase III study. http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.7035. Published May 2017. Accessed November 20, 2017.
7. Appelbaum FR, Bernstein ID. Gemtuzumab ozogamicin for acute myeloid leukemia. http://www.bloodjournal.org/content/early/2017/10/11/blood-2017-09-797712?sso-checked=true. September 2017. Accessed November 20, 2017.
8. Kim G, Ison G, McKee AE, et al. FDA approval summary: olaparib monotherapy in patients with deleterious germline BRCA-mutated advanced ovarian cancer treated with three or more lines of chemotherapy. Clin Cancer Res. 2015;21:4257-4261.
9. Swisher EM, Lin KK, Oza AM, et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017;18:75-87.
10. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154-2164.
11. Kim DW, Tiseo M, Ahn MJ, Reckamp KL, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol. 2017;35(22):2490-2498.
12. Soria J-C, Tan DSW, MD, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017;389(10072):917-929.
13. Apolo AB, Infante JR, Balmanoukian A et al. Avelumab, an anti–programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol. 2017;35(19):2117-2124.
14. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti–programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol. 2016;34(26):3119-3125.
15. Dreyling M, Morschhauser F, Bouabdallah K, et al. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017;28(9):2169-2178.
16. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. https://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0250-9. Published March 9, 2016. Accessed November 20, 2017.
17. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.
18. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017;25(1):285-295.
With advances in the understanding of cellular pathways, molecular genetics, and immunology, new drugs for cancer are being released at an increasing rate. A variety of novel agents have recently become available for use, generating excitement for patients and oncologists. Keeping track of all of these new agents is increasingly challenging. This brief review will summarize some of the newest drugs, their indications, and benefits (see related article).
Therapies by tumor
Breast cancer
CDK4/6 inhibitors. The CDK4/6 inhibitor palbociclib was approved in 2015 for the treatment of estrogen-positive, HER2-negative advanced breast cancer, and this year, two more drugs in this class – ribociclib and abemaciclib – were approved for the treatment of hormone receptor–positive breast cancer.
Ribociclib (Kisqali) 600 mg daily (3 weeks on, 1 week off) is approved for use in combination with an aromatase inhibitor. In the study on which the approval was based, there was a response rate of 53% for patients in the study group, compared with 37% for those who received aromatase inhibitor alone (progression-free survival (PFS), not reached vs 14.7 months for single-agent aromatase inhibitor).1 The occurrence of neutropenia seemed to be similar to that in patients receiving palbociclib. However, unlike with palbociclib, ribociclib requires ECG monitoring for QTc prolongation as well as monitoring of liver function tests.
Abemaciclib (Verzenio) has been approved in combination with fulvestrant as well as a monotherapy.2 PFS was 16.4 months for abemaciclib (150 mg bid in combination with fulvestrant), compared with 9.3 months for fulvestrant alone, with corresponding response rates of 48% and 21%. As monotherapy, abemaciclib 200 mg bid had a response rate of 20% with a duration of response of 8.6 months.
Tyrosine kinase inhibitors. The tyrosine kinase inhibitor neratinib (Nerlynx) was approved for extended adjuvant treatment of HER2-positive breast cancer after 1 year of adjuvant trastuzumab.3 Given at 240 mg (6 tablets) daily for a year, compared with a no-treatment control arm, it demonstrated an improvement in invasive disease-free survival (DFS) at 2 years from 91.9% to 94.2%, with no difference in overall survival yet noted. It is associated with diarrhea and also requires hepatic function monitoring.
Acute myelogenous leukemia
Multiple new agents were recently approved for use in acute myelogenous leukemia (AML), after decades of slow advance in new drug development.
Midostaurin (Rydapt) is an FLT3 inhibitor approved for use in combination with daunorubicin and Ara-C (cytosine arabinoside) for newly diagnosed AML with FLT3 mutations, which occur in about 30% of AML patients.4 It is given orally on days 8-21 at 50 mg bid with induction and consolidation.
In the study on which the approval was based, there was a 10% improvement in overall survival for this subset of AML patients who have a typically a worse prognosis. Event-free survival in patients in the study group was 8.2 months, compared with 3 months in the control arm patients, who did not receive the agent. The drug was also approved for aggressive systemic mastocytosis.
Enasidenib (Idhifa) has been approved for AML with an IDH2 mutation in the refractory/relapsed settings.5IDH2 mutations are present in about 20% of patients with AML. Given orally at 100 mg daily as a single agent, enasidenib was associated with a 19% complete remission rate. Patients need to be monitored for differentiation syndrome, somewhat similar to what is seen with ATRA with acute promyelocytic leukemia.
Liposomal daunorubicin and cytarabine (Vyxeos) was approved for newly diagnosed therapy- or myelodysplasia-related AML.6 This novel liposomal formulation combines two standard agents and is given intravenously on days 1, 3 and 5 over 90 minutes as daunorubicin 44 mg/m2 and cytarabine 100 mg/ m2. (For a second induction and in lower dose on consolidation cycles, it is given only on days 1 and 3). The liposomal formulation achieved a superior complete response rate compared with the standard 7+3 daunorubicin plus cytarabine regimen (38% vs 26%, respectively) and longer overall survival (9.6 versus 5.9 months) in these generally poor prognosis subsets.
Gemtuzumab ozogamicin (Mylotarg) was initially approved in 2000 but withdrawn from use in 2010 after trials failed to confirm benefit and demonstrated safety concerns. It has now been re-released in a lower dose and schedule from its original label.7 This immunoconjugate of an anti-CD33 bound to calicheamicin is approved for CD33-positive AML. Given at 3 mg/m2 on days 1, 4, and 7 in combination with standard daunorubicin–cytarabine induction chemotherapy, it improved event-free survival from 9.5 to 17.3 months. When administered as a single agent (6 mg/m2 on day 1 and 3 mg/m2 on day 8) in patients who were unable or unwilling to tolerate standard chemotherapy, it improved overall survival (4.9 months versus 3.6 months for best supportive care). As a single agent in relapsed AML, given at 3 mg/m2 days 1, 4, and 7 and followed by cytarabine consolidation, it was associated with a 26% complete response rate, with a median relapse-free survival of 11.6 months.
Ovarian/fallopian tube cancers
PARP inhibitors. For patients with ovarian/fallopian tube cancer, there are new indications and agents for PARP inhibition, including for patients with BRCA mutations (both somatic and germline) and those without BRCA mutations.
Olaparib (Lynparza) was previously approved only in a fourth-line setting for germline BRCA-mutated patients with advanced ovarian cancer, with a response rate of 34% with a median duration of 7.9 months. Given at 300 mg orally bid, it is now approved for use in maintenance in recurrence after response to platinum-based chemotherapy after 2 or more lines of therapy regardless of BRCA status. In this setting, progression-free survival increased to 8.4 months, compared with 4.8 months for placebo.8
Rubicarib (Rubraca) is approved for BRCA-mutated patients (either germline or somatic) with advanced ovarian cancer after two or more lines of chemotherapy.9 At 600 mg orally bid, results from phase 2 trials noted a 54% response rate, with a median duration of 9.2 months.
Niraparib (Zejula) is approved for use in maintenance in recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers after platinum-based chemotherapy.10 In patients with germline BRCA mutations, niraparib at 300 mg orally daily resulted in a PFS of 21 months, compared with 5.5 months with placebo; PFS in patients with nongermline BRCA mutations was 9.3 versus 3.9 months, respectively.
Non-small cell lung cancer with EML-4 alk translocation
Crizotinib (Xalkori) has been the mainstay for treatment of for EML4-alk translocated non-small cell lung cancer. However, alectinib (Alcensa), previously for predominantly second-line use, seems more active than crizotinib in the first-line setting, particularly in the treatment and prevention of CNS metastases.
In addition, brigantinib (Alunbrig) has been approved for patients who are intolerant/refractory to crizotinib.11 At 90 mg once daily for 7 days, then escalating to 180 mg daily, it was noted to have a 50% response rate in crizotinib failures, including in the CNS.
Ceritinib (Zykadia) was approved at 750 mg once daily for EML4 alk positive NSCLC.12 In first line it had a response rate of 73% (versus 27% for chemotherapy) with a remission duration of 23.9 months (versus 11.1 months for chemotherapy).
Therapies by drug class
PD-1/PD-L1 antibodies
Anti-PD-1 antibodies nivolumab (Opdivo) and pembrolizumab (Keytruda) are widely used for a range of tumor types. Newer approvals for pembrolizumab are for adenocarcinoma of the stomach/gastro-esophageal junction with at least 1% PD-L1 expression, and in any tumor demonstrated to be MSI-high. Newer indications for nivolumab are for bladder cancer, MSI-high colon cancer, and for hepatoma previously treated with sorafenib. The anti-PD-L1 antibody atezolizumab (Tencentriq) is now approved for platinum-resistant metastatic lung cancer, in addition to platinum-ineligible and platinum-resistant urothelial cancer.
Avelumab (Bavencio) is an anti-PD-L1 approved for both Merkel cell and previously treated urothelial cancers at a dose of 10 mg/kg every 2 weeks.13 It demonstrated a 33% response rate for Merkel cell and a 16% response rate for urothelial cancer.
Durvalumab (Imfinzi) is another anti PD-L1 antibody approved at 10 mg/kg every 2 weeks for previously treated urothelial cancer with a 17% response rate (RR: PD-L1 high, 26%; low, 4%).14
PI3K kinase inhibitors
Copanlisib (Aliqopa) is a PI3K inhibitor approved for relapsed follicular lymphoma in patients who have progressed after two previous lines of therapy.15 It is a 60-mg, 1-hour infusion given on days 1, 8, and 15 every 28 days. In a phase 2 tria
BTK inhibitors
Acalabruitnib (Calquence) is approved for adults with previously treated mantle cell lymphoma. In a phase 2 trial at 100 mg orally bid, it achieved an 80% overall and 40% complete response rate.16 These response rates are higher than were seen for ibrutinib in its original phase 2 trial. The spectrum of toxicities seems similar to ibruitinib and includes bleeding, cytopenias, infection, and atrial fibrillation.
CD19 CAR-T cells
Perhaps the most exciting and novel new agents are genetically engineered autologous T cells. Tisagenlecleucel (Kymriah), a chimeric antigen receptor T cell (CART) that targets CD19 is approved for refractory B cell precursor acute lymphoblastic leukemia (in patients under 25 years) where the complete response rate was 83% (including patients with incomplete blood count recovery).17
Axicabtagene ciloleucel (aci-cel; Yescarta), also CD19-directed CART, is approved for adults with relapsed or refractory non-Hodgkin lymphoma after two lines of previous therapy (specifically large-cell lymphoma, primary mediastinal large B-cell lymphoma, and transformed follicular lymphoma). Response rate was 72% (complete, 51%; partial, 21%), with a median duration of response of 9.2 months.18
With advances in the understanding of cellular pathways, molecular genetics, and immunology, new drugs for cancer are being released at an increasing rate. A variety of novel agents have recently become available for use, generating excitement for patients and oncologists. Keeping track of all of these new agents is increasingly challenging. This brief review will summarize some of the newest drugs, their indications, and benefits (see related article).
Therapies by tumor
Breast cancer
CDK4/6 inhibitors. The CDK4/6 inhibitor palbociclib was approved in 2015 for the treatment of estrogen-positive, HER2-negative advanced breast cancer, and this year, two more drugs in this class – ribociclib and abemaciclib – were approved for the treatment of hormone receptor–positive breast cancer.
Ribociclib (Kisqali) 600 mg daily (3 weeks on, 1 week off) is approved for use in combination with an aromatase inhibitor. In the study on which the approval was based, there was a response rate of 53% for patients in the study group, compared with 37% for those who received aromatase inhibitor alone (progression-free survival (PFS), not reached vs 14.7 months for single-agent aromatase inhibitor).1 The occurrence of neutropenia seemed to be similar to that in patients receiving palbociclib. However, unlike with palbociclib, ribociclib requires ECG monitoring for QTc prolongation as well as monitoring of liver function tests.
Abemaciclib (Verzenio) has been approved in combination with fulvestrant as well as a monotherapy.2 PFS was 16.4 months for abemaciclib (150 mg bid in combination with fulvestrant), compared with 9.3 months for fulvestrant alone, with corresponding response rates of 48% and 21%. As monotherapy, abemaciclib 200 mg bid had a response rate of 20% with a duration of response of 8.6 months.
Tyrosine kinase inhibitors. The tyrosine kinase inhibitor neratinib (Nerlynx) was approved for extended adjuvant treatment of HER2-positive breast cancer after 1 year of adjuvant trastuzumab.3 Given at 240 mg (6 tablets) daily for a year, compared with a no-treatment control arm, it demonstrated an improvement in invasive disease-free survival (DFS) at 2 years from 91.9% to 94.2%, with no difference in overall survival yet noted. It is associated with diarrhea and also requires hepatic function monitoring.
Acute myelogenous leukemia
Multiple new agents were recently approved for use in acute myelogenous leukemia (AML), after decades of slow advance in new drug development.
Midostaurin (Rydapt) is an FLT3 inhibitor approved for use in combination with daunorubicin and Ara-C (cytosine arabinoside) for newly diagnosed AML with FLT3 mutations, which occur in about 30% of AML patients.4 It is given orally on days 8-21 at 50 mg bid with induction and consolidation.
In the study on which the approval was based, there was a 10% improvement in overall survival for this subset of AML patients who have a typically a worse prognosis. Event-free survival in patients in the study group was 8.2 months, compared with 3 months in the control arm patients, who did not receive the agent. The drug was also approved for aggressive systemic mastocytosis.
Enasidenib (Idhifa) has been approved for AML with an IDH2 mutation in the refractory/relapsed settings.5IDH2 mutations are present in about 20% of patients with AML. Given orally at 100 mg daily as a single agent, enasidenib was associated with a 19% complete remission rate. Patients need to be monitored for differentiation syndrome, somewhat similar to what is seen with ATRA with acute promyelocytic leukemia.
Liposomal daunorubicin and cytarabine (Vyxeos) was approved for newly diagnosed therapy- or myelodysplasia-related AML.6 This novel liposomal formulation combines two standard agents and is given intravenously on days 1, 3 and 5 over 90 minutes as daunorubicin 44 mg/m2 and cytarabine 100 mg/ m2. (For a second induction and in lower dose on consolidation cycles, it is given only on days 1 and 3). The liposomal formulation achieved a superior complete response rate compared with the standard 7+3 daunorubicin plus cytarabine regimen (38% vs 26%, respectively) and longer overall survival (9.6 versus 5.9 months) in these generally poor prognosis subsets.
Gemtuzumab ozogamicin (Mylotarg) was initially approved in 2000 but withdrawn from use in 2010 after trials failed to confirm benefit and demonstrated safety concerns. It has now been re-released in a lower dose and schedule from its original label.7 This immunoconjugate of an anti-CD33 bound to calicheamicin is approved for CD33-positive AML. Given at 3 mg/m2 on days 1, 4, and 7 in combination with standard daunorubicin–cytarabine induction chemotherapy, it improved event-free survival from 9.5 to 17.3 months. When administered as a single agent (6 mg/m2 on day 1 and 3 mg/m2 on day 8) in patients who were unable or unwilling to tolerate standard chemotherapy, it improved overall survival (4.9 months versus 3.6 months for best supportive care). As a single agent in relapsed AML, given at 3 mg/m2 days 1, 4, and 7 and followed by cytarabine consolidation, it was associated with a 26% complete response rate, with a median relapse-free survival of 11.6 months.
Ovarian/fallopian tube cancers
PARP inhibitors. For patients with ovarian/fallopian tube cancer, there are new indications and agents for PARP inhibition, including for patients with BRCA mutations (both somatic and germline) and those without BRCA mutations.
Olaparib (Lynparza) was previously approved only in a fourth-line setting for germline BRCA-mutated patients with advanced ovarian cancer, with a response rate of 34% with a median duration of 7.9 months. Given at 300 mg orally bid, it is now approved for use in maintenance in recurrence after response to platinum-based chemotherapy after 2 or more lines of therapy regardless of BRCA status. In this setting, progression-free survival increased to 8.4 months, compared with 4.8 months for placebo.8
Rubicarib (Rubraca) is approved for BRCA-mutated patients (either germline or somatic) with advanced ovarian cancer after two or more lines of chemotherapy.9 At 600 mg orally bid, results from phase 2 trials noted a 54% response rate, with a median duration of 9.2 months.
Niraparib (Zejula) is approved for use in maintenance in recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancers after platinum-based chemotherapy.10 In patients with germline BRCA mutations, niraparib at 300 mg orally daily resulted in a PFS of 21 months, compared with 5.5 months with placebo; PFS in patients with nongermline BRCA mutations was 9.3 versus 3.9 months, respectively.
Non-small cell lung cancer with EML-4 alk translocation
Crizotinib (Xalkori) has been the mainstay for treatment of for EML4-alk translocated non-small cell lung cancer. However, alectinib (Alcensa), previously for predominantly second-line use, seems more active than crizotinib in the first-line setting, particularly in the treatment and prevention of CNS metastases.
In addition, brigantinib (Alunbrig) has been approved for patients who are intolerant/refractory to crizotinib.11 At 90 mg once daily for 7 days, then escalating to 180 mg daily, it was noted to have a 50% response rate in crizotinib failures, including in the CNS.
Ceritinib (Zykadia) was approved at 750 mg once daily for EML4 alk positive NSCLC.12 In first line it had a response rate of 73% (versus 27% for chemotherapy) with a remission duration of 23.9 months (versus 11.1 months for chemotherapy).
Therapies by drug class
PD-1/PD-L1 antibodies
Anti-PD-1 antibodies nivolumab (Opdivo) and pembrolizumab (Keytruda) are widely used for a range of tumor types. Newer approvals for pembrolizumab are for adenocarcinoma of the stomach/gastro-esophageal junction with at least 1% PD-L1 expression, and in any tumor demonstrated to be MSI-high. Newer indications for nivolumab are for bladder cancer, MSI-high colon cancer, and for hepatoma previously treated with sorafenib. The anti-PD-L1 antibody atezolizumab (Tencentriq) is now approved for platinum-resistant metastatic lung cancer, in addition to platinum-ineligible and platinum-resistant urothelial cancer.
Avelumab (Bavencio) is an anti-PD-L1 approved for both Merkel cell and previously treated urothelial cancers at a dose of 10 mg/kg every 2 weeks.13 It demonstrated a 33% response rate for Merkel cell and a 16% response rate for urothelial cancer.
Durvalumab (Imfinzi) is another anti PD-L1 antibody approved at 10 mg/kg every 2 weeks for previously treated urothelial cancer with a 17% response rate (RR: PD-L1 high, 26%; low, 4%).14
PI3K kinase inhibitors
Copanlisib (Aliqopa) is a PI3K inhibitor approved for relapsed follicular lymphoma in patients who have progressed after two previous lines of therapy.15 It is a 60-mg, 1-hour infusion given on days 1, 8, and 15 every 28 days. In a phase 2 tria
BTK inhibitors
Acalabruitnib (Calquence) is approved for adults with previously treated mantle cell lymphoma. In a phase 2 trial at 100 mg orally bid, it achieved an 80% overall and 40% complete response rate.16 These response rates are higher than were seen for ibrutinib in its original phase 2 trial. The spectrum of toxicities seems similar to ibruitinib and includes bleeding, cytopenias, infection, and atrial fibrillation.
CD19 CAR-T cells
Perhaps the most exciting and novel new agents are genetically engineered autologous T cells. Tisagenlecleucel (Kymriah), a chimeric antigen receptor T cell (CART) that targets CD19 is approved for refractory B cell precursor acute lymphoblastic leukemia (in patients under 25 years) where the complete response rate was 83% (including patients with incomplete blood count recovery).17
Axicabtagene ciloleucel (aci-cel; Yescarta), also CD19-directed CART, is approved for adults with relapsed or refractory non-Hodgkin lymphoma after two lines of previous therapy (specifically large-cell lymphoma, primary mediastinal large B-cell lymphoma, and transformed follicular lymphoma). Response rate was 72% (complete, 51%; partial, 21%), with a median duration of response of 9.2 months.18
1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748.
2. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646.
3. Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17(3):367-377.
4. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454-464.
5. Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731.
6. Lancet JE, Rizzieri D, Schiller GJ, et al. Overall survival (OS) with CPX-351 versus 7+3 in older adults with newly diagnosed, therapy-related acute myeloid leukemia (tAML): subgroup analysis of a phase III study. http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.7035. Published May 2017. Accessed November 20, 2017.
7. Appelbaum FR, Bernstein ID. Gemtuzumab ozogamicin for acute myeloid leukemia. http://www.bloodjournal.org/content/early/2017/10/11/blood-2017-09-797712?sso-checked=true. September 2017. Accessed November 20, 2017.
8. Kim G, Ison G, McKee AE, et al. FDA approval summary: olaparib monotherapy in patients with deleterious germline BRCA-mutated advanced ovarian cancer treated with three or more lines of chemotherapy. Clin Cancer Res. 2015;21:4257-4261.
9. Swisher EM, Lin KK, Oza AM, et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017;18:75-87.
10. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154-2164.
11. Kim DW, Tiseo M, Ahn MJ, Reckamp KL, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol. 2017;35(22):2490-2498.
12. Soria J-C, Tan DSW, MD, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017;389(10072):917-929.
13. Apolo AB, Infante JR, Balmanoukian A et al. Avelumab, an anti–programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol. 2017;35(19):2117-2124.
14. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti–programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol. 2016;34(26):3119-3125.
15. Dreyling M, Morschhauser F, Bouabdallah K, et al. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017;28(9):2169-2178.
16. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. https://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0250-9. Published March 9, 2016. Accessed November 20, 2017.
17. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.
18. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017;25(1):285-295.
1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med. 2016;375(18):1738-1748.
2. Goetz MP, Toi M, Campone M, et al. MONARCH 3: Abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638-3646.
3. Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17(3):367-377.
4. Stone RM, Mandrekar SJ, Sanford BL, et al. Midostaurin plus chemotherapy for acute myeloid leukemia with a FLT3 mutation. N Engl J Med. 2017;377(5):454-464.
5. Stein EM, DiNardo CD, Pollyea DA, et al. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731.
6. Lancet JE, Rizzieri D, Schiller GJ, et al. Overall survival (OS) with CPX-351 versus 7+3 in older adults with newly diagnosed, therapy-related acute myeloid leukemia (tAML): subgroup analysis of a phase III study. http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.7035. Published May 2017. Accessed November 20, 2017.
7. Appelbaum FR, Bernstein ID. Gemtuzumab ozogamicin for acute myeloid leukemia. http://www.bloodjournal.org/content/early/2017/10/11/blood-2017-09-797712?sso-checked=true. September 2017. Accessed November 20, 2017.
8. Kim G, Ison G, McKee AE, et al. FDA approval summary: olaparib monotherapy in patients with deleterious germline BRCA-mutated advanced ovarian cancer treated with three or more lines of chemotherapy. Clin Cancer Res. 2015;21:4257-4261.
9. Swisher EM, Lin KK, Oza AM, et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol. 2017;18:75-87.
10. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154-2164.
11. Kim DW, Tiseo M, Ahn MJ, Reckamp KL, et al. Brigatinib in patients with crizotinib-refractory anaplastic lymphoma kinase-positive non-small-cell lung cancer: a randomized, multicenter phase II trial. J Clin Oncol. 2017;35(22):2490-2498.
12. Soria J-C, Tan DSW, MD, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. Lancet. 2017;389(10072):917-929.
13. Apolo AB, Infante JR, Balmanoukian A et al. Avelumab, an anti–programmed death-ligand 1 antibody, in patients with refractory metastatic urothelial carcinoma: results from a multicenter, phase Ib study. J Clin Oncol. 2017;35(19):2117-2124.
14. Massard C, Gordon MS, Sharma S, et al. Safety and efficacy of durvalumab (MEDI4736), an anti–programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol. 2016;34(26):3119-3125.
15. Dreyling M, Morschhauser F, Bouabdallah K, et al. Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. Ann Oncol. 2017;28(9):2169-2178.
16. Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. https://jhoonline.biomedcentral.com/articles/10.1186/s13045-016-0250-9. Published March 9, 2016. Accessed November 20, 2017.
17. Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371(16):1507-1517.
18. Locke FL, Neelapu SS, Bartlett NL, et al. Phase 1 results of ZUMA-1: a multicenter study of KTE-C19 anti-CD19 CAR T cell therapy in refractory aggressive lymphoma. Mol Ther. 2017;25(1):285-295.
Breast cancer: More pathogenic variants detected as multiple-gene sequencing takes over
The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.
Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.
That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.
“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.
Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.
Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.
Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).
Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).
While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.
They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.
They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.
“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.
Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.
SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.
The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.
Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.
That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.
“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.
Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.
Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.
Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).
Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).
While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.
They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.
They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.
“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.
Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.
SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.
The introduction of multiple-gene sequencing led to a substantial increase in detection of pathogenic variants in a study of women with breast cancer treated in community practice, results of one retrospective study show.
Multiple-gene sequencing rapidly replaced BRCA1/2 only testing over a 2-year period in the study, driven in part by technological advances and regulatory changes that made comprehensive low-cost genetic testing more accessible, investigators wrote. The report was published in JAMA Oncology.
That quick uptake increased detection of genetic variants that could change care, with no associated increase in prophylactic mastectomy over that same time period, said Allison W. Kurian, MD, of Stanford (Calif.) University, and her coinvestigators.
“The greater yield of clinically relevant information with multiple-gene sequencing offers a major potential advantage over more limited BRCA1/2-only tests,” noted Dr. Kurian and her colleagues.
Their analysis included 5,026 women with stage 0-II breast cancer diagnosed from January 2013 to December 2015 and enrolled in the Individualized Cancer Care (iCan Care) study. That study started enrolling 1 month before a U.S. Supreme Court decision on gene patents, which led to lower costs for multiple-gene sequencing tests for breast cancer risk, Dr. Kurian and her coinvestigators said.
Overall, about one-quarter of women in the study had genetic testing, and that did not change over time. What did change over time was the number of women undergoing multiple-gene testing: In 2013, only 25.6% underwent multiple-gene sequencing, versus 74.4% for BRCA1/2-only testing; by 2015, those figures flipped to 66.5% and 33.5%, respectively.
Multiple-gene sequencing increased detection of pathogenic variants in women at average pretest risk (4.2% versus 2.2% for BRCA1/2-only testing), according to the reported data. Detection was increased in women at high pretest risk due to young age, triple-negative breast cancer, or other factors (12% versus 7.8%).
Prophylactic mastectomy was most strongly associated with detection of pathogenic BRCA1/2 variants, according to Dr. Kurian and her coinvestigators. More women with those variants strongly considered the procedure and had it recommended by their surgeons, and ultimately, significantly more underwent the procedure (79.0% versus 37.6% for other pathogenic variants; P less than .001).
While those mastectomy outcomes were reassuring, Dr. Kurian and her colleagues said, their research uncovered two “important limitations” to multiple-gene sequencing that should be addressed.
They found that testing was done post surgically in 32.5% of women who had multiple-gene sequencing, compared with 19.9% of women who had BRCA1/2-only testing. Postsurgical testing is “too late” and limits its use to make decisions about surgical prevention of second cancers, they said.
They also found racial disparities in detection of variants of unknown significance (VUS). In particular, VUS were detected in 23.7% of white patients, compared with 44.5% of black patients and 50.9% of Asian patients. That’s because most of the genes were first sequenced in white patients, the investigators noted.
In previous experience with BRCA1/2 testing, extensive VUS reclassification occurred after broader testing within the population over 2 decades.
“It is a crucial priority to resolve persistent racial/ethnic disparities in genetic information, particularly as increasingly comprehensive sequencing tests enter clinical practice,” the investigators wrote.
Dr. Kurian reported that Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.
SOURCE: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.
FROM JAMA ONCOLOGY
Key clinical point: For breast cancer patients in community practice, multiple-gene sequencing has rapidly replaced BRCA1/2-only testing, increasing detection of pathogenic variants with no associated increase in prophylactic mastectomy.
Major finding: The rate of pathogenic variant detection was substantially increased with multiple-gene sequencing versus BRCA1/2 only testing for higher-risk patients (12% versus 7.8%) and average risk patients (4.2% versus 2.2%).
Study details: A population-based retrospective cohort study of 5,026 patients with breast cancer diagnosed from January 2013 to December 2015.
Disclosures: Stanford University received research funding from Myriad Genetics for an unrelated project. No other conflicts of interest were reported.
Source: Kurian AW et al. JAMA Oncol. 2018 May 10. doi: 10.1001/jamaoncol.2018.0644.
Intravenous antiemetic combination is well tolerated
An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.
Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.
After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.
Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.
There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.
“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.
“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.
Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.
Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.
SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.
An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.
Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.
After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.
Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.
There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.
“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.
“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.
Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.
Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.
SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.
An intravenous combination of fosnetupitant and palonosetron is as well tolerated as is the oral combination for the management of chemotherapy-induced nausea and vomiting, according to a double-blind phase 3 study.
Researchers randomized 404 chemotherapy-naive patients undergoing highly emetogenic chemotherapy for solid tumors to receive a single intravenous dose of 235 mg fosnetupitant and 0.25 mg palonosetron (NEPA) 30 minutes before chemotherapy, or an oral formulation 60 minutes before chemotherapy, with matching placebos.
After a mean of 3.3 doses of intravenous formulation or 3.2 doses of oral formulation, there were similar numbers of treatment-emergent adverse events in the intravenous and oral groups (83.3% vs. 86.6%) but no serious treatment-related adverse events, the investigators wrote. The report was published in Annals of Oncology.
Nearly half of patients in both groups experienced severe adverse events over the course of the study, the most common being neutropenia, anemia, and leukopenia. The most common overall adverse events that occurred during the course of treatment were constipation and increased alanine aminotransferase.
There were very few infusion site treatment-emergent adverse events and none of these were judged to be related to the intravenous infusion of the drug combination.
“Infusion site reactions have been reported for fosaprepitant and IV rolapitant and the product labeling for both includes precaution/warning statements regarding the potential for hypersensitivity reactions/anaphylaxis; in addition, marketed distribution of IV rolapitant was recently suspended as a result of anaphylaxis/anaphylactic shock and hypersensitivity reactions reported in the post-marketing setting,” wrote Lee Schwartzberg, MD, of West Cancer Center, Germantown, Tenn., and his coauthors.
“In light of this, it is noteworthy that there were no injection site reactions considered to be related to IV NEPA over repeated cycles and no instance of anaphylaxis with either formulation of NEPA,” they wrote.
Overall, complete response rates for cycle 1 of treatment were 76.8% in the intravenous group and 84.1% in the oral treatment group, and no emesis rates were also similar (84.2% vs. 88.6%). However, the authors noted that the study was not powered to compare the efficacy of the two formulations.
Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.
SOURCE: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.
FROM ANNALS OF ONCOLOGY
Key clinical point: Intravenous fosnetupitant and palonosetron are as well tolerated as is oral formulation.
Major finding: Treatment-emergent adverse events were similar for intravenous and oral fosnetupitant and palonosetron combination.
Study details: Double-blind, randomized phase 3 study of 404 patients undergoing chemotherapy.
Disclosures: Helsinn Healthcare sponsored the study and provided the drugs. Two authors were employees of the company, and four were consultants for the company. Two authors declared research support, advisory roles, and honoraria from pharmaceutical companies including Helsinn Healthcare. Three authors declared no conflicts of interest.
Source: Schwartzberg L et al. Ann Oncol. 2018 May 10. doi: 10.1093/annonc/mdy169/4990798.
Novel targeted cancer drugs cause fewer arrhythmias
ORLANDO – Not all oncology drugs are equal when it comes to their risk of treatment-induced cardiac arrhythmias.
Indeed, compared with anthracycline-based regimens, long the workhorse in treating many forms of cancer, the novel targeted agents – tyrosine kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies – were 40% less likely to result in a new arrhythmia diagnosis within 6 months of treatment initiation, in a large, single-center retrospective study reported by Andrew Nickel at the annual meeting of the American College of Cardiology.
Overall, 14% of cancer patients developed a first-ever cardiac arrhythmia within the first 6 months after treatment began. In a Cox multivariate analysis, treatment with a targeted cancer agent was independently associated with a 40% lower risk of arrhythmia, compared with anthracycline-containing therapy. Of note, the incidence of new-onset atrial fibrillation was closely similar in the two groups.
Several patient factors emerged as independent predictors of increased risk of cancer treatment–induced arrhythmia in the multivariate analysis: male sex, with a 1.2-fold increased risk; baseline heart failure, with a 2.2-fold risk; and hypertension, which conferred a 1.6-fold increased risk. These are patient groups in which the novel targeted cancer treatments are a particularly attractive option from the standpoint of mitigating arrhythmia risk, provided their use would be appropriate, he observed.
Mr. Nickel reported having no financial conflicts regarding his study, which was conducted free of commercial support.
SOURCE: Nickel A et al. ACC 18. Abstract 900-06.
ORLANDO – Not all oncology drugs are equal when it comes to their risk of treatment-induced cardiac arrhythmias.
Indeed, compared with anthracycline-based regimens, long the workhorse in treating many forms of cancer, the novel targeted agents – tyrosine kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies – were 40% less likely to result in a new arrhythmia diagnosis within 6 months of treatment initiation, in a large, single-center retrospective study reported by Andrew Nickel at the annual meeting of the American College of Cardiology.
Overall, 14% of cancer patients developed a first-ever cardiac arrhythmia within the first 6 months after treatment began. In a Cox multivariate analysis, treatment with a targeted cancer agent was independently associated with a 40% lower risk of arrhythmia, compared with anthracycline-containing therapy. Of note, the incidence of new-onset atrial fibrillation was closely similar in the two groups.
Several patient factors emerged as independent predictors of increased risk of cancer treatment–induced arrhythmia in the multivariate analysis: male sex, with a 1.2-fold increased risk; baseline heart failure, with a 2.2-fold risk; and hypertension, which conferred a 1.6-fold increased risk. These are patient groups in which the novel targeted cancer treatments are a particularly attractive option from the standpoint of mitigating arrhythmia risk, provided their use would be appropriate, he observed.
Mr. Nickel reported having no financial conflicts regarding his study, which was conducted free of commercial support.
SOURCE: Nickel A et al. ACC 18. Abstract 900-06.
ORLANDO – Not all oncology drugs are equal when it comes to their risk of treatment-induced cardiac arrhythmias.
Indeed, compared with anthracycline-based regimens, long the workhorse in treating many forms of cancer, the novel targeted agents – tyrosine kinase inhibitors, immune checkpoint inhibitors, and monoclonal antibodies – were 40% less likely to result in a new arrhythmia diagnosis within 6 months of treatment initiation, in a large, single-center retrospective study reported by Andrew Nickel at the annual meeting of the American College of Cardiology.
Overall, 14% of cancer patients developed a first-ever cardiac arrhythmia within the first 6 months after treatment began. In a Cox multivariate analysis, treatment with a targeted cancer agent was independently associated with a 40% lower risk of arrhythmia, compared with anthracycline-containing therapy. Of note, the incidence of new-onset atrial fibrillation was closely similar in the two groups.
Several patient factors emerged as independent predictors of increased risk of cancer treatment–induced arrhythmia in the multivariate analysis: male sex, with a 1.2-fold increased risk; baseline heart failure, with a 2.2-fold risk; and hypertension, which conferred a 1.6-fold increased risk. These are patient groups in which the novel targeted cancer treatments are a particularly attractive option from the standpoint of mitigating arrhythmia risk, provided their use would be appropriate, he observed.
Mr. Nickel reported having no financial conflicts regarding his study, which was conducted free of commercial support.
SOURCE: Nickel A et al. ACC 18. Abstract 900-06.
REPORTING FROM ACC 2018
Key clinical point: The novel targeted cancer therapies cause markedly fewer cardiac arrhythmias.
Major finding: Cancer patients treated with a tyrosine kinase inhibitor, immune checkpoint inhibitor, or another of the novel targeted therapies were 40% less likely than were those on anthracycline-based therapy to develop a treatment-induced cardiac arrhythmia up to 6 months after treatment initiation.
Study details: This was a retrospective single-center study including more than 5,000 cancer patients.
Disclosures: The presenter reported having no financial conflicts regarding his study, which was conducted free of commercial support.
Source: Nickel A et al. ACC 18, Abstract #900-06.
Patient Knowledge of and Barriers to Breast, Colon, and Cervical Cancer Screenings: A Cross-Sectional Survey of TRICARE Beneficiaries (FULL)
The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.1 These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).
Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.2 Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.
Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.
Methods
A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)
All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.
The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.
Data Elements
The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.
Survey Mode and Fielding
A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.
Sample Weighting and Statistical Analysis
Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.
Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.
Results
A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).
Barriers to Screening
A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.
Screening Preferences
Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.
The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.
Breast Cancer Screening
Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.
The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).
Cervical Cancer Screening
Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.5 Among all respondents, 98% reported having had a cervical cancer screening.
Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.
To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).
Colorectal Cancer Screening
Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).
Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.
Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.
Discussion
The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.
More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.8 In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.7
For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.13 These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.
A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.16
A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.15 The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.18
Strengths and Limitations
A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.21 A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.
There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.
A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.
Conclusion
Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.
Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
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1. TRICARE. TRICARE policy manual 6010.57-M. http://manuals.tricare.osd.mil/pages/DisplayManualaspx?SeriesId=POLICY. Published February 1, 2008. Accessed March 9, 2017.
2. National Committee for Quality Assurance. 2013 accreditation benchmarks and thresholds—mid-year update. http://www.ncqa.org/Portals/0/PolicyUpdates/Trending %20and%20Benchmarks/archives/2013_BENCHMARKS ANDTHRESHOLDS_for%20MidYear%20Update_Final.pdf. Published July 24, 2013. Accessed March 9, 2017.
3. U.S. Preventative Services Task Force. Archived final recommendation statement: breast cancer: screening, 2002. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-screening-2002. Published December 30, 2013. Accessed March 9, 2017.
4. Smith RA, Saslow D, Sawyer KA, et al; American Cancer Society High-Risk Work Group; American Cancer Society Screening Older Women Work Group; American Cancer Society Mammography Work Group; American Cancer Society Physical Examination Work Group; American Cancer Society New Technologies Work Group; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast cancer screening: update 2003. CA Cancer J Clin. 2003;53(3):141-169.
5. Moyer VA; U.S. Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;156(12):880-891, W312.
6. U.S. Preventive Services Task Force. Archived: colorectal cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening. Published October 2008. Accessed March 9, 2017.
7. George SA. Barriers to breast cancer screening: an integrative review. Health Care Women Int. 2000;21(1):53-65.
8. Gierisch JM, O’Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009;33(1):72-78.
9. Peppercorn J, Houck K, Beri N, et al. Breast cancer screening utilization and understanding of current guidelines among rural U.S. women with private insurance. Breast Cancer Res Treat. 2015;153(3):659-667.
10. Sarma EA. Barriers to screening mammography. Health Psychol Rev. 2015;9(1):42-62.
11. Hawkins NA, Benard VB, Greek A, Roland KB, Manninen D, Saraiya M. Patient knowledge and beliefs as barriers to extending cervical cancer screening intervals in federally qualified health centers. Prev Med. 2013;57(5):641-645.
12. Hawkins NA, Cooper CP, Saraiya M, Gelb CA, Polonec L. Why the Pap test? Awareness and use of the Pap test among women in the United States. J Womens Health (Larchmt). 2011;20(4):511-515.
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18. Klabunde CN, Schenck AP, Davis WW. Barriers to colorectal cancer screening among Medicare consumers. Am J Prev Med. 2006;30(4):313-319.
19. Klabunde CN, Vernon SW, Nadel MR, Breen N, Seeff LC, Brown ML. Barriers to colorectal cancer screening: a comparison of reports from primary care physicians and average-risk adults. Med Care. 2005;43(9):939-944.
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21. Pew Research Center. Assessing the representativeness of public opinion surveys. http://www.people-press.org/2012/05/15/assessing-the-representativeness-of-public-opinion-surveys/. Published May 15, 2012. Accessed March 9, 2017.
The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.1 These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).
Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.2 Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.
Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.
Methods
A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)
All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.
The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.
Data Elements
The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.
Survey Mode and Fielding
A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.
Sample Weighting and Statistical Analysis
Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.
Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.
Results
A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).
Barriers to Screening
A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.
Screening Preferences
Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.
The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.
Breast Cancer Screening
Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.
The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).
Cervical Cancer Screening
Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.5 Among all respondents, 98% reported having had a cervical cancer screening.
Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.
To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).
Colorectal Cancer Screening
Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).
Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.
Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.
Discussion
The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.
More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.8 In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.7
For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.13 These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.
A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.16
A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.15 The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.18
Strengths and Limitations
A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.21 A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.
There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.
A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.
Conclusion
Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.
Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
Click here to read the digital edition.
The National Defense Appropriations Act for fiscal year 2009, Subtitle B, waived copayments for preventive cancer screening services for all TRICARE beneficiaries, excluding Medicare-eligible beneficiaries.1 These preventive services include screening for colorectal cancer (CRC), breast cancer, and cervical cancer based on current guidelines (eAppendix1).
Despite having unrestricted access to these cancer screenings, TRICARE Prime beneficiaries report overall screening completion rates that are below the national commercial benchmarks established by the Healthcare Effectiveness Data and Information Set (HEDIS) for all 3 cancer types.2 Specifically, among TRICARE Prime beneficiaries enrolled in the western region of the U.S. in October 2013, the reported breast cancer screening rate was 61.6% (43,138/69,976) for women aged 42 to 69 years, which is well below the HEDIS 75th percentile of 76%. Similarly, the reported rate of cervical cancer screening among women aged 24 to 64 years was 68.3% (63,523/92,946), well below the HEDIS 75th percentile of 79%. Last, the reported rate of CRC screening among male and female TRICARE Prime members aged 51 to 75 years was 61.6% (52,860/85,827), also below the 2013 HEDIS 75th percentile of 63% based on internal review of TRICARE data used for HEDIS reporting.
Given the reported low screening rates, the Defense Health Agency (DHA) performed a cross-sectional survey to assess TRICARE Prime West region beneficiaries’ knowledge and understanding of preventive health screening, specifically for breast cancer, cervical cancer, and CRC, and to identify any potential barriers to access for these screenings.
Methods
A mostly closed-ended, 42-item telephone survey was designed and conducted (eAppendix2)
All women participating in the survey, regardless of age, were asked questions regarding cervical cancer screening. Women aged ≥ 42 years additionally were asked a second set of survey questions specific to breast cancer screening, and women aged between 51 and 64 years were asked a third set of questions related to CRC screening. The ages selected were 1 to 2 years after the recommended age for the respective screening to ensure adequate follow-up time for the member to obtain the screening. Men included in the survey were asked questions related only to CRC screening.
The target survey sample was 3,500 beneficiaries, separated into the following 4 strata: women aged 21 to 64 years of age enrolled in the direct care system (n = 1,250); women aged 21 to 64 years enrolled in the purchased (commercial) care network (n = 1,250); men aged 51 to 64 years enrolled in the direct care system (n = 500); and men aged 51 to 64 years enrolled in the purchased care network (n = 500). The random sample was drawn from an overall population of about 35,000 members. Sampling was performed without replacement until the target number of surveys was achieved. Survey completion was defined as the respondent having reached the end of the survey questionnaire but not necessarily having answered every question.
Data Elements
The preventive health survey collected information on beneficiaries’ knowledge of and satisfaction with their PCM, the primary location where they sought health care in the previous 12 months, preference for scheduling cancer screening tests, and general knowledge about the frequency and type of screening for breast, cervical, and colorectal cancers. Responses were scored based on guidelines effective as of 2009. In addition, the survey collected information on the beneficiary’s overall health status, current age, highest level of education achieved, current employment status, place of residence (on or off a military installation), race, and whether the beneficiary carried other health insurance aside from TRICARE.
Survey Mode and Fielding
A sampling population of eligible beneficiaries was created from a database of all TRICARE Prime beneficiaries. An automated system was used to randomly draw potential participants from the sample. Survey interviewers were given the beneficiary’s name and telephone number but no other identifiable information. Phone numbers from the sample were dialed up to 6 times before the number was classified as a “no answer.” Interviewers read to each beneficiary a statement describing the survey and participation risk and benefits and explained that participation was voluntary and the participant could end the survey at any time without penalty or prejudice. The survey commenced only after verbal consent was obtained.
Sample Weighting and Statistical Analysis
Each survey record was weighted to control for potential bias associated with unequal rates of noncoverage and nonresponse in the sampled population. A design weight was calculated as the ratio of the frame size and the sample size in each stratum. For each stratum, an adjusted response rate (RR) was calculated as the number of completed surveys divided by the number of eligible respondents. Since all respondents were eligible, the RR was not adjusted. The ratio of the design weight to the adjusted RR was calculated and assigned to each survey.
Frequency distributions and descriptive statistics were calculated for all close-ended survey items. Open-ended survey items were summarized and assessed qualitatively. When appropriate, open-ended responses were categorized and included in descriptive analyses. No formal statistical testing was performed.
Results
A total of 6,563 beneficiaries were contacted, and 3,688 agreed to participate (56%), resulting in 3,500 TRICARE beneficiaries completing the survey (95% completion rate), of whom 71% (2,500) were female. The overall cooperation rates were similar across the 4 strata. Interviews ceased once 3,500 surveys were completed. The largest distribution of respondents was aged between 55 and 64 years (37%) (Table 1). Respondents aged 21 to 24 years comprised the smallest percentage of the sample (7%). Nearly a third of respondents were dependents of ADSMs (30%), another 30% were retirees, and most respondents self-identified as white (Table 1).
Barriers to Screening
A series of survey questions was asked about specific barriers to cancer screening, including the convenience of appointment times for the respondent’s last cancer screening. The majority (69%, 2,415 of 3,500) responded that the appointment times were convenient. Among those who stated that times were not convenient and those who had not scheduled an examination, 66% responded that they did not know or were not sure how to schedule a cancer screening test.
Screening Preferences
Less than half of survey respondents (48%) reported that they received screening guideline information from their physician or provider; 24% reported that they performed their own research. Only 9% reported that they learned about the guidelines through TRICARE materials, and 7% of respondents indicated that media, family, or friends were their source of screening information.
The survey respondents who indicated that they had not scheduled a screening examination were asked when (time of day) they preferred to have a screening. Less than half (47%) reported that varying available appointment times would not affect their ability to obtain screening. One-quarter preferred times for screening during working hours, 20% preferred times after working hours, 6% preferred times before working hours, and 2% responded that they were unsure or did not know. The majority (89%) reported that they would prefer to receive all available screenings on the same day if possible.
Breast Cancer Screening
Nearly all (98%) of the 1,100 women aged between 42 and 64 years reported having received a mammogram. These women were asked a specific subset of questions related to breast cancer screening. Respondents were asked to state the recommended age at which women should begin receiving mammogram screenings. More than half (55%) provided the correct response (40 years old, per the U.S. Preventive Services Task Force guidelines).3,4 About three-quarters of respondents (789) correctly responded annually to the question regarding how often women should receive mammograms.
The survey also sought to identify barriers that prevented women from obtaining necessary breast cancer screening. However, the majority surveyed (85%) noted that the question was not applicable because they typically scheduled screening appointments. Only a few (3%) reported factors such as either themselves or someone they know having had a negative experience, discomfort, pain, or concerns of a falsepositive result as reasons for not obtaining breast cancer screening. Of the 112 respondents to the open-ended question, 25% reported that their schedules prevented them from scheduling a mammogram in the past; 12% reported that an inconvenient clinic location, appointment time, or process prevented them from receiving a screening; and 13% reported forgetting to schedule the screening (Table 2).
Cervical Cancer Screening
Female respondents aged between 21 and 64 years (n = 2,432) were asked about the recommended age at which women should begin receiving cervical cancer screening. Only 1% of respondents provided the correct response (that screening begins at 21 years of age per the U.S. Preventive Services Task Force Report guidelines), while 88% provided an incorrect response, and 11% were unsure or did not provide any response.5 Among all respondents, 98% reported having had a cervical cancer screening.
Respondents were asked how frequently women should have a Papanicolaou (Pap) test. Responses such as “2 to 3 years,” “2 years,” or “every other year” were labeled as correct, whereas responses such as “every 6 months” or “greater than 3 years” were labeled as incorrect. Just 12% of respondents provided a correct response, whereas 86% answered incorrectly, and 2% did not answer or did not know. Of those who answered incorrectly, the most common response was “annually” or “every year,” with no notable differences according to race, age, or beneficiary category.
To better understand barriers to screening, respondents were asked to identify reasons they might not have sought cervical cancer screening. The majority (84%) reported that they typically scheduled appointments and that the question was not applicable. However, among 228 respondents who provided an open-ended response and who had not previously undergone a hysterectomy, 8% stated that they had received no reminder or that they lacked sufficient information to schedule the appointment, 21% forgot to schedule, 18% reported a scheduling conflict or difficulty in receiving care, and 13% noted that they did not believe in annual screening (Table 2).
Colorectal Cancer Screening
Eighty-seven percent of eligible respondents (n = 1,734) reported having ever had a sigmoidoscopy and/or colonoscopy. Respondents were asked for their understanding of the recommended age for men and women to begin CRC screening.6 Nearly three-quarters of respondents provided a correct response (n = 1,225), compared with 23% of respondents (n = 407) who answered incorrectly and 6% (n = 102) who did not provide a response or stated they did not know. Correct responses were numerically higher among white respondents (73%) compared with black (62%) and other (62%) respondents as well as among persons aged < 60 years (73%) vs those aged > 60 years (67%).
Respondents aged between 51 and 64 years were asked how often the average person should receive colon cancer screenings. The most common response was that screening should occur every 5 years (33%) followed by every 10 years (26%). This aligns with the U.S. Preventive Services Task Force’s recommendations for flexible sigmoidoscopy every 5 years or colonoscopy every 10 years.
Eligible respondents were asked to identify reasons they did not seek CRC screening. Eighty-six percent of respondents indicated that they typically scheduled CRC screening and that the question was not applicable. Among respondents who provided an open-ended response, 26% cited feeling uncomfortable with the procedure, 15% cited forgetting to schedule a screening, 15% noted a lack of information on screening, and 11% reported no need for screening (Table 2). Among the 1,734 respondents, 80% reported that they would prefer a fecal occult blood test (FOBT) over either a colonoscopy or a sigmoidoscopy. Only 51% reported that their PCM had previously discussed the different types of CRC screenings at some point.
Discussion
The purpose of this large, representative survey was to obtain information on beneficiaries’ knowledge, perceived barriers, and beliefs regarding breast, cervical, and colorectal cancer screenings to identify factors contributing to low completion rates. As far as is known, this is the first study to address these questions in a TRICARE population. Overall, the findings suggest that beneficiaries consider cancer screening important, largely relying on their PCM or their research to better understand how and when to obtain such screenings. The majority received 1 or more screenings prior to the survey, but there were some common knowledge gaps about how to schedule screening appointments, relevant TRICARE medical benefits, and the current recommendations regarding screening timing and frequency. A commonly reported issue across all surveyed groups was inconvenient screening times.
More than half (55%) of respondents correctly noted that breast cancer screening begins at age 40 years (based on recommendations at the time the survey was conducted), and 72% understood when screening should occur. Despite access to care, inconvenient schedules and testing locations were considered the biggest barriers to regularly obtaining a mammogram. There are few studies on knowledge of breast cancer screening in an insured population available for comparison.7-10 One study of medically insured black and non-Hispanic women aged 43 to 49 years showed that lack of reminders or knowledge about the need for mammograms, cost, being too busy, and forgetting to schedule appointments were all factors associated with nonadherence to repeat mammography examinations.8 In an integrative review published in 2000, authors cited that among 8 of 13 relevant studies, the major barrier to receiving a recommended mammogram was lack of physician recommendation.7
For cervical cancer screening, few respondents (1%) correctly identified the age for initiation of screening, and just 12% correctly identified the frequency of screening. These findings are consistent with those of other studies, suggesting a general misunderstanding
about Pap tests in the U.S. and among low-income women.11,12 Reported barriers to screening were uncommon but included scheduling conflicts and lack of reminders or information and were consistent with barriers cited in prior studies.13,14 A few respondents (13%) noted that they did not believe in annual screening, which is similar to the findings of Decker and colleagues who cited lack of knowledge about the test and belief that screening is of no benefit as reasons for failure to get a recommended Pap test.13 These findings suggest a need to improve patientprovider communication and to provide more patient educational materials about the importance of cervical cancer screening.
A large proportion (71%) gave the correct response regarding the appropriate age to initiate CRC screening. Discomfort with the procedure, belief that the screening is unnecessary, or lack of physician’s recommendation were noted barriers to CRC screening. These findings are similar to those reported elsewhere in non-TRICARE populations.15-20 Two focus groups included participants with little knowledge about CRC screening, such as risk factors and symptoms, and expressed fear and embarrassment about CRC and screening. Few of the focus group participants were aware of the available options for screening, and some were confused about the purpose and benefits of the various screening modalities.16
A Health Information National Trends survey reported that 24% participants had not received a colonoscopy or a sigmoidoscopy because their PCM did not order it or say that it was necessary.15 The reported perceived barriers included fear of an adverse finding, injury to the colon from screening, and embarrassment. A study performed in 1,901 Medicare-insured individuals with no history of CRC cited lack of knowledge/awareness and no physician order as the most common reasons for not undergoing CRC screening.18
Strengths and Limitations
A major strength of the current survey is the 56% completion rate, which far exceeds other survey participation rates that were as low as 9%.21 A second strength is the scope of the survey to capture information on not 1 but 3 different cancer screening practices in a unique population who receive preventive screenings at low to no cost.
There are a few study limitations. The majority of respondents identified as white (80%), which does not fully align with the racial distribution of the TRICARE Prime population in the West Region, which is about 68% white. This higher proportion of white respondents may affect the ability to generalize findings to other populations. However, given the open access to care, race should not be a major factor contributing to screening decisions. Another potential limitation to the generalizability of the study is that the age of the respondents was capped at 64 years. Considering that some of the reported barriers to screening were “too busy” or “scheduling conflict,” a study population that included respondents aged ≥ 65 years (who might be more likely to be retired) might report lower rates of these schedule-related barriers.
A third limitation is that most questions about prior screenings pertained to any time in the past, and, therefore, limited the ability to identify current factors leading to lower screening rates. Last, the survey was developed prior to the 2012 changes in cervical and breast cancer screening recommendations and was therefore scored based on prior recommendations. Given that the goal was to assess knowledge and barriers, results are not expected to differ greatly if they are scored using the newer guidelines.
Conclusion
Findings from this cross-sectional survey indicate high levels of knowledge among TRICARE West Region beneficiaries regarding when and how often screening for breast cancer, cervical cancer, and CRC should occur. To encourage TRICARE beneficiaries to seek and obtain recommended and covered cancer screenings, further efforts are needed, including more education about the importance of screening and how to obtain screening. The survey results suggest that TRICARE Prime beneficiaries view cancer screening as important for overall health but they require (and also may desire) more frequent scheduling reminders, education, and more options for scheduling. Newer modalities for communicating with beneficiaries, such as automated telephone appointment reminders, reminder texts, online appointment scheduling, educational blogs, podcasts on cancer screening, extended appointment hours, or unconventional strategies to bundle screening services, are tools that could be used by providers to achieve greater compliance with cancer screening recommendations.
Author Disclosure
The authors report no actual or potential conflicts of interest with regard to this article.
Disclaimer
The opinions expressed herein are those of the authors and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies.
Click here to read the digital edition.
1. TRICARE. TRICARE policy manual 6010.57-M. http://manuals.tricare.osd.mil/pages/DisplayManualaspx?SeriesId=POLICY. Published February 1, 2008. Accessed March 9, 2017.
2. National Committee for Quality Assurance. 2013 accreditation benchmarks and thresholds—mid-year update. http://www.ncqa.org/Portals/0/PolicyUpdates/Trending %20and%20Benchmarks/archives/2013_BENCHMARKS ANDTHRESHOLDS_for%20MidYear%20Update_Final.pdf. Published July 24, 2013. Accessed March 9, 2017.
3. U.S. Preventative Services Task Force. Archived final recommendation statement: breast cancer: screening, 2002. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-screening-2002. Published December 30, 2013. Accessed March 9, 2017.
4. Smith RA, Saslow D, Sawyer KA, et al; American Cancer Society High-Risk Work Group; American Cancer Society Screening Older Women Work Group; American Cancer Society Mammography Work Group; American Cancer Society Physical Examination Work Group; American Cancer Society New Technologies Work Group; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast cancer screening: update 2003. CA Cancer J Clin. 2003;53(3):141-169.
5. Moyer VA; U.S. Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;156(12):880-891, W312.
6. U.S. Preventive Services Task Force. Archived: colorectal cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening. Published October 2008. Accessed March 9, 2017.
7. George SA. Barriers to breast cancer screening: an integrative review. Health Care Women Int. 2000;21(1):53-65.
8. Gierisch JM, O’Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009;33(1):72-78.
9. Peppercorn J, Houck K, Beri N, et al. Breast cancer screening utilization and understanding of current guidelines among rural U.S. women with private insurance. Breast Cancer Res Treat. 2015;153(3):659-667.
10. Sarma EA. Barriers to screening mammography. Health Psychol Rev. 2015;9(1):42-62.
11. Hawkins NA, Benard VB, Greek A, Roland KB, Manninen D, Saraiya M. Patient knowledge and beliefs as barriers to extending cervical cancer screening intervals in federally qualified health centers. Prev Med. 2013;57(5):641-645.
12. Hawkins NA, Cooper CP, Saraiya M, Gelb CA, Polonec L. Why the Pap test? Awareness and use of the Pap test among women in the United States. J Womens Health (Larchmt). 2011;20(4):511-515.
13. Decker KM, Turner D, Demers AA, Martens PJ, Lambert P, Chateau D. Evaluating the effectiveness of cervical cancer screening invitation letters. J Womens Health (Larchmt). 2013;22(8):687-693.
14. Yao X, Dembe AE, Wickizer T, Lu B. Does time pressure create barriers for people to receive preventive health services? Prev Med. 2015;74:55-58.
15. Geiger TM, Miedema BW, Geana MV, Thaler K, Rangnekar NJ, Cameron GT. Improving rates for screening colonoscopy: analysis of the Health Information National Trends Survey (HINTS I) data. Surgical Endoscopy. 2008;22(2):527-533.
16. Greisinger A, Hawley ST, Bettencourt JL, Perz CA, Vernon SW. Primary care patients’ understanding of colorectal cancer screening. Cancer Detect Prev. 2006;30(1):67-74.
17. Janz NK, Wren PA, Schottenfeld D, Guire KE. Colorectal cancer screening attitudes and behavior: a populationbased study. Prev Med. 2003;37(6, pt 1):627-634.
18. Klabunde CN, Schenck AP, Davis WW. Barriers to colorectal cancer screening among Medicare consumers. Am J Prev Med. 2006;30(4):313-319.
19. Klabunde CN, Vernon SW, Nadel MR, Breen N, Seeff LC, Brown ML. Barriers to colorectal cancer screening: a comparison of reports from primary care physicians and average-risk adults. Med Care. 2005;43(9):939-944.
20. Berkowitz Z, Hawkins NA, Peipins LA, White MC, Nadel MR. Beliefs, risk perceptions, and gaps in knowledge as barriers to colorectal cancer screening in older adults. J Am Geriatr Soc. 2008;56(2):307-314.
21. Pew Research Center. Assessing the representativeness of public opinion surveys. http://www.people-press.org/2012/05/15/assessing-the-representativeness-of-public-opinion-surveys/. Published May 15, 2012. Accessed March 9, 2017.
1. TRICARE. TRICARE policy manual 6010.57-M. http://manuals.tricare.osd.mil/pages/DisplayManualaspx?SeriesId=POLICY. Published February 1, 2008. Accessed March 9, 2017.
2. National Committee for Quality Assurance. 2013 accreditation benchmarks and thresholds—mid-year update. http://www.ncqa.org/Portals/0/PolicyUpdates/Trending %20and%20Benchmarks/archives/2013_BENCHMARKS ANDTHRESHOLDS_for%20MidYear%20Update_Final.pdf. Published July 24, 2013. Accessed March 9, 2017.
3. U.S. Preventative Services Task Force. Archived final recommendation statement: breast cancer: screening, 2002. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/breast-cancer-screening-2002. Published December 30, 2013. Accessed March 9, 2017.
4. Smith RA, Saslow D, Sawyer KA, et al; American Cancer Society High-Risk Work Group; American Cancer Society Screening Older Women Work Group; American Cancer Society Mammography Work Group; American Cancer Society Physical Examination Work Group; American Cancer Society New Technologies Work Group; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast cancer screening: update 2003. CA Cancer J Clin. 2003;53(3):141-169.
5. Moyer VA; U.S. Preventive Services Task Force. Screening for cervical cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012;156(12):880-891, W312.
6. U.S. Preventive Services Task Force. Archived: colorectal cancer: screening. https://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-cancer-screening. Published October 2008. Accessed March 9, 2017.
7. George SA. Barriers to breast cancer screening: an integrative review. Health Care Women Int. 2000;21(1):53-65.
8. Gierisch JM, O’Neill SC, Rimer BK, DeFrank JT, Bowling JM, Skinner CS. Factors associated with annual-interval mammography for women in their 40s. Cancer Epidemiol. 2009;33(1):72-78.
9. Peppercorn J, Houck K, Beri N, et al. Breast cancer screening utilization and understanding of current guidelines among rural U.S. women with private insurance. Breast Cancer Res Treat. 2015;153(3):659-667.
10. Sarma EA. Barriers to screening mammography. Health Psychol Rev. 2015;9(1):42-62.
11. Hawkins NA, Benard VB, Greek A, Roland KB, Manninen D, Saraiya M. Patient knowledge and beliefs as barriers to extending cervical cancer screening intervals in federally qualified health centers. Prev Med. 2013;57(5):641-645.
12. Hawkins NA, Cooper CP, Saraiya M, Gelb CA, Polonec L. Why the Pap test? Awareness and use of the Pap test among women in the United States. J Womens Health (Larchmt). 2011;20(4):511-515.
13. Decker KM, Turner D, Demers AA, Martens PJ, Lambert P, Chateau D. Evaluating the effectiveness of cervical cancer screening invitation letters. J Womens Health (Larchmt). 2013;22(8):687-693.
14. Yao X, Dembe AE, Wickizer T, Lu B. Does time pressure create barriers for people to receive preventive health services? Prev Med. 2015;74:55-58.
15. Geiger TM, Miedema BW, Geana MV, Thaler K, Rangnekar NJ, Cameron GT. Improving rates for screening colonoscopy: analysis of the Health Information National Trends Survey (HINTS I) data. Surgical Endoscopy. 2008;22(2):527-533.
16. Greisinger A, Hawley ST, Bettencourt JL, Perz CA, Vernon SW. Primary care patients’ understanding of colorectal cancer screening. Cancer Detect Prev. 2006;30(1):67-74.
17. Janz NK, Wren PA, Schottenfeld D, Guire KE. Colorectal cancer screening attitudes and behavior: a populationbased study. Prev Med. 2003;37(6, pt 1):627-634.
18. Klabunde CN, Schenck AP, Davis WW. Barriers to colorectal cancer screening among Medicare consumers. Am J Prev Med. 2006;30(4):313-319.
19. Klabunde CN, Vernon SW, Nadel MR, Breen N, Seeff LC, Brown ML. Barriers to colorectal cancer screening: a comparison of reports from primary care physicians and average-risk adults. Med Care. 2005;43(9):939-944.
20. Berkowitz Z, Hawkins NA, Peipins LA, White MC, Nadel MR. Beliefs, risk perceptions, and gaps in knowledge as barriers to colorectal cancer screening in older adults. J Am Geriatr Soc. 2008;56(2):307-314.
21. Pew Research Center. Assessing the representativeness of public opinion surveys. http://www.people-press.org/2012/05/15/assessing-the-representativeness-of-public-opinion-surveys/. Published May 15, 2012. Accessed March 9, 2017.
Integrating survivorship care planning in radiation oncology workflow
In January 2016 there were an estimated 15.5 million people in the United States who were living with a cancer diagnosis, representing 4.8% of the population. That number is expected to increase to 20.3 million by 2026.1 The 5-year relative survival rate for all cancers diagnosed during 2005 to 2011 was 69%.2 As more individuals with a cancer diagnosis now live longer, cancer survivorship is receiving increased attention. A report from the Institute of Medicine3 identified the essential components of survivorship care, including the provision of a survivorship care plan (SCP) containing specific diagnosis, treatment, and follow-up information (Table 1). To maintain accreditation in their respective organizations, the American College of Surgeons’ Commission on Cancer and the National Accreditation Program for Breast Centers (NAPBC) have included standards on providing treatment summaries and SCPs in person to those patients who have completed cancer treatments given with curative intent.4,5
SCPs are personalized documents presented to cancer patients at the end of treatment that summarize key aspects of cancer treatment and recommend appropriate ongoing medical care and self-management. The purpose of the SCP is both to educate cancer survivors and to create a portable document that can be shared with primary care providers to facilitate coordinated care.6 There are multiple barriers to SCP implementation, which may include the time required to create an SCP, inadequate reimbursement for the time spent creating and delivering the plan, a lack of risk-stratified guidelines for coordinated care, and the incomplete automation of diagnosis and treatment summarization by the electronic health record (EHR).7
Survivorship care in radiation oncology
The American College of Radiology includes the recommendation for regular, ongoing follow-up in the standards for accreditation for radiation oncology practice.8 Radiation oncology practices often provide the initial follow-up appointment about a month after the prescribed radiation treatment has been completed. The twofold purpose of this appointment is to assess the response to treatment and to evaluate acute treatment-related effects.9 The appointment may include a skin evaluation, assessment for any acute treatment effects, informal counseling on maintaining a healthy lifestyle, and recommendations for posttreatment care and follow-up. The appointment may also be an opportune time for delivering the SCP because radiation therapy is often the final treatment modality in active therapy for breast cancer patients.
A review of the literature yields scant data on the incorporation of SCPs into a radiation oncology practice. A 2014 survey of members of the American Society of Radiation Oncology10for a response percentage of 14.7%. Almost all providers follow their patients after treatment (97% (n = 574 respondents/3987 total membership, 14.4% response rate) showed that although most radiation oncologists provide long-term follow-up care to their patients after treatment completion (97%), fewer than half of those surveyed indicated that they delivered SCPs for curative-intent patients (40%), and even fewer delivered for palliative-intent patients (19%). Standards for the American Society for Radiation Oncology’s Accreditation Program for Excellence11 outline content for end-of-treatment documentation. Typically, the documentation includes a detailed treatment summary prepared by the treating radiation oncologist. This treatment summary includes the patient’s diagnosis, the area treated, radiation doses received, number of fractions delivered, therapy start date, therapy completion date, and overall tolerance of treatment in a clinical summary. The treatment summary is communicated to other providers involved in the patient’s care to promote care coordination, but it is not typically provided to patients.
Development of University of Wisconsin survivorship care planning
As an important component of maintaining NAPBC accreditation, the University of Wisconsin (UW) Health Breast Center began the process of formalizing and optimizing SCPs for breast cancer survivors who are followed at the center. Multidisciplinary input from surgical, medical, and radiation oncology was obtained. Representatives from those disciplines met regularly to reach consensus on the treatment summary and SCP content. The following 3 documents were created for use during a transition visit at the end of treatment: the written individualized SCP to be provided to the survivor and his/her primary care providers, a general survivorship patient education booklet, and a patient questionnaire to identify survivors’ concerns and additional resources that may be beneficial.
Treatment summary
Working in collaboration with IT specialists, we enabled out-of-the-box functionality within our EHR. This cancer-specific functionality provides a central and standard location within each survivor’s problem list to systematically document information regarding cancer diagnosis, stage, and treatment associated with a specific cancer diagnosis. Each treating provider (surgeon, medical oncologist, radiation oncologist, genetic counselor, etc) is responsible for entering and updating the relevant components within the treatment summary (ie, the surgeon enters and maintains the surgical details, the medical oncologist does likewise for chemotherapy and other medical therapies, etc). Information is updated and current, creating a dynamic documentation of diagnosis and treatment that can be used in clinic notes, patient after-visit summaries, and SCPs.
Survivorship care plan
This same EHR functionality is leveraged to generate, populate, and maintain the individualized SCP for each breast cancer survivor. The Treatment Summary section of the SCP can be quickly prepared within the EHR by autopopulating data previously entered by treating providers. Content and language for SCP templates in breast, colorectal, prostate, and gynecologic cancers are in use at the time of publication. The templates are developed as a collaborative effort between oncology subspecialists, with input from the UW Health survivor and family advocacy councils.
Each template contains a Treatment Summary section and an SCP section. The Treatment Summary section includes survivor general information, diagnosis and treatment information, and the clinical and supportive/survivor care team names and contact information. The SCP section includes follow-up recommendations, signs of recurrence and/or symptoms to report, healthy lifestyle and maintenance, chronic or late effects of specific treatment if applicable (eg, surgery, chemotherapy by drug, radiation therapy, and endocrine therapy), and general resources for common psychosocial concerns (Table 1).12,13
Each SCP is visible to the entire health care team, including other specialists and primary care, as long as they have access to UW Health’s EHR.14 The result is a readily accessible, comprehensive document that is individualized for each survivor, residing in a standard location with standardized format and content to facilitate review and use.15
General survivorship patient education booklet
Many cancer survivors request additional information about their posttreatment concerns. The “UW Health Facts for You: Cancer Survivorship, Carbone Cancer Center” booklet was developed by a multidisciplinary team including oncologists, advanced practice providers (APPs), navigators, social workers, program leadership, cancer survivors, and caregivers. The guide includes detailed information for the cancer survivor on topics including nutrition, exercise, sleep, tobacco cessation, sexual health, and spirituality. Common concerns and symptom management are addressed as well as a comprehensive list of community resources. The booklet can be found at http://www.uwhealth.org/healthfacts/cancer/7834.
Survivorship questionnaire
Breast cancer survivors often have multiple concerns as they transition from active treatment to the survivorship phase of their cancer journey. Specific concerns may vary slightly form one survivor to another. Guided by recommendations for the American Society of Clinical Oncology and the National Comprehensive Cancer Network, we developed a 10-question, 2-page questionnaire to identify those concerns with input from members of the Breast Cancer Steering Committee. Members of the committee include surgical, medical, and radiation oncologists, AAPs, radiologists, pathologists, program leadership, and nurses, along with breast cancer survivors. Elements in the questionnaire include nutrition, activity, mood, sleep, sexual health, employment/insurance, pain/swelling, desires regarding pregnancy or prevention, memory/concentration, smoking, alcohol, genetic testing/counseling, and assistance with establishing care with a primary care provider. By completing the questionnaire, breast cancer survivors identify specific concerns within each category and are able to request additional information about those concerns and/or a referral to appropriate resources. They may also select the I need nothing further option if the concern is present but already being addressed.
SCP delivery and the transition visit
The next task in implementation of the care process for survivors encompassed the development of clinical workflows and processes to provide the document to the breast cancer survivor at the completion of treatment. In a study of breast cancer survivors, it was found that the preferred format for survivorship care planning is generally an in-person consultation at completion of treatment with an oncology professional.16 The best time for distribution of the written SCP is, however, unclear. Intuitively, it seems optimal to distribute SCPs around the time of completion of active treatment. However, for SCP delivery to be feasible and sustainable, delivery must be integrated into existing clinical care-delivery processes, and content must be streamlined and focused to meet the needs of their intended recipients without becoming overly burdensome to prepare and deliver.17
Ultimately, and after significant multidisciplinary discussion, it was determined that Stage 0-III breast cancer patients would have a visit focusing on symptoms and transitioning to surveillance follow-up (Transition Visit) as they completed active curative-intent cancer treatment. During this Transition Visit, the SCP document would be provided and reviewed with survivors. The Transition Visit for breast cancer survivors would be conducted by an APP following the completion of their final stage of active, primary treatment (surgery, chemotherapy, and/or radiation therapy). Additional long-term adjuvant therapy for breast cancer survivors (ie, trastuzumab, endocrine therapy) would continue as indicated during and after delivery of the SCP.
The radiation oncology clinic was chosen as a venue for these Transition Visits for breast cancer survivors whose treatment included radiotherapy. Despite little historical experience with delivery of SCPs in radiation oncology clinics, this was a logical choice given that radiotherapy is usually the final phase of active treatment for these breast cancer survivors, and a follow-up visit about a month after completing radiotherapy is already part of standard practice. Collaborating with the multidisciplinary UW Health Breast Center, we therefore integrated the formal breast survivorship care planning process and provision of the SCP into the current radiation oncology workflow. About 40% of the roughly 600 breast cancer patients treated by surgical and/or medical oncology at our institution annually also receive radiation therapy at our site. For the remaining 60% of breast cancer survivors who do not receive radiation therapy or who completed radiotherapy at an outside facility, the SCP is provided by an APP within the UW Health Breast Center.
UW radiation oncology survivorship transition visit
The overall workflow of our Transition Visit is depicted in the Figure. Toward the end of the breast cancer survivor’s radiation treatments, the radiation oncologist instructs the schedulers to arrange the 1-month, post-radiation Transition Visit with the APP and informs the survivor about the nature of the appointment. The Transition Visit is scheduled as a 60-minute appointment. Before the survivor’s arrival, an APP generates the written SCP. The activity includes completing the Treatment Summary, or verifying the accuracy of a prepopulated Treatment Summary, and individualizing the SCP section for the patient based on treatment received and follow-up recommendations using drop-down functionality. As the SCP is printed for review with the survivor, it is simultaneously sent to the survivor’s primary care provider. This is accomplished by using EHR functionality to route the document internally to UW primary care providers or automatically faxing the document to external primary care providers. Each SCP is also marked as complete within the EHR for the purposes of documenting compliance with this activity for later data analysis.
On arrival for the appointment, each breast cancer survivor completes the survivorship questionnaire. During the Transition Visit, the questionnaire is reviewed with the survivor and additional information is provided. Referral options are discussed if indicated with desired referrals made by the APP. The survivor is interviewed and examined for any persistent side effects of treatment. Next, the Treatment Summary and SCP are reviewed with the survivor, emphasizing the follow-up plan, signs or symptoms of breast cancer recurrence, and chronic or late treatment-related toxicities. Ample opportunity is provided for the survivor to ask questions and voice concerns.
Follow-up appointments with members of the patient’s care team (ie, medical, surgical, or radiation oncology) as well as necessary breast imaging (ie, mammogram, MRI) are coordinated and scheduled before the survivor leaves the department. A survey of oncologists (medical, surgical, radiation) identified specific cancer-related components of survivorship care that oncologists felt most responsible for as well as opportunities to improve the quality and efficiency of care provided by oncologists.18 At our institution, the breast surgical, medical, and radiation oncologists all generally participate in follow-up care through at least 1 year following completion of active, primary treatment.
Outcomes, quality improvement opportunities, and continued challenges with the process
There is presently a lack of long-term outcome data about the impact of SCPs. As mandates for the provision of SCPs are made, research focusing on whether SCPs result in improved health behaviors and outcomes, reduced burden in care transitions from the oncology setting, and increased cost-effectiveness will be needed.19 The long-term effects of SCPs on psychological, oncologic, and resource outcomes should be evaluated,20 as well as the impact on health behaviors, such as smoking cessation or participation in rehabilitation programs.21
Following the implementation of our Transition Visits in 2015, we conducted a quality improvement review. This review included summation of 69 recent breast cancer questionnaires from Transition Visits with our APPs (Table 2 and Table 3). The most common concerns raised by our breast cancer survivors include desire for weight loss, improving diet, and increasing physical activity. Of note, concerns did not often translate into a desire for more information or referrals.22 Survivors were generally satisfied with the timing of the Transition Visits and generally indicated that the visits were helpful, with self-reported improvements in their understanding of planned follow-up. A Canadian group evaluating breast and head and neck cancer survivors has suggested that SCPs could produce long-term improvements in healthy lifestyle behaviors; however, further research is needed to determine the extent to which SCPs might improve follow-up care over the long term.23
Finally, although efforts to date have been focused on the breast cancer survivor at the completion of treatment, long-term survivors may also benefit from receiving the SCP. A study by the American Cancer Society found that long-term cancer survivors had unmet informational needs, particularly with regard to screening, long-term cancer and treatment effects, and healthy lifestyle behaviors.24 Identifying and subsequently delivering an SCP to eligible long-term survivors is a challenging prospect, which depends on further refinement of EHR-based tracking of the date of diagnosis, cancer stage, and end-of-treatment date.
Summary and recommendations
Survivorship care has been efficiently integrated into our 1-month post-radiation follow-up appointment for breast cancer survivors. By using current resources in the radiation oncology department, the process has provided an effective way to deliver the SCP to breast cancer survivors. Future plans include implementing the process for all patients receiving curative-intent radiation for additional solid tumor survivors. Quality improvement projects will be developed to assess survivor satisfaction and the impact on health behaviors.
Acknowledgments
The authors thank Amy Heath, MS, RTT, for editorial and manuscript preparation assistance.
1. Statistics. National Cancer Institute, Division of Cancer Control & Population Sciences website. http:///cancercontrol.cancer.gov/ocs/statistics/statistics.html. Updated October 17, 2016. Accessed March 6, 2018.
2. Cancer facts & figures 2016. American Cancer Society website. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html. Published 2016. Accessed February 27, 2018.
3. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academies Press; 2006.
4. Knutson A, McNamara E. Cancer program standards: ensuring patient-centered care. American College of Surgeons website. https://www.facs.org/quality-programs/cancer/coc/standards. Published August 2016. Accessed March 6, 2018.
5. National Accreditation Program for Breast Centers. NAPBC standards manual. American College of Surgeons website. https://www.facs.org/~/media/files/quality%20programs/napbc/2014%20napbc%20standards%20manual.ashx. Published 2014. Accessed March 6, 2018.
6. Salz T, McCabe MS, Onstad EE, et al. Survivorship care plans: is there buy-in from community oncology providers? Cancer. 2014;120(5):722-730.
7. Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK, Wollins DS, Shulman LN. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning. J Oncol Pract. 2014;10(6):345-351.
8. Dobelbower RR, Cotter G, Schilling PJ, Parsai EI, Carroll JM. Radiation oncology practice accreditation. Rays. 2001;26(3):191-198.
9. Hartford AC, Conway PD, Desai NB, et al. ACR-ASTRO practice parameter for communication: radiation oncology. The American College of Radiology website. http://www.acr.org/-/media/ACR/Files/Practice-Parameters/RadOnc.pdf. Updated 2014. Accessed March 6, 2018.
10. Koontz BF, Benda R, De Los Santos J, et al. US radiation oncology practice patterns for posttreatment survivor care. Pract Radiat Oncol. 2016;6(1):50-56.
11. American Society of Therapeutic Radiation Oncologists. APEx program standards. ASTRO website. http://www.astro.org/uploadedFiles/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Published February 1, 2016. Accessed March 6, 2018.
12. Clinical practice survivorship guidelines and adaptations. American Society of Clinical Oncology website. http://www.asco.org/practice-guidelines/cancer-care-initiatives/prevention-survivorship. Published 2013. Accessed March 6, 2018.
13. National Comprehensive Cancer Network. Supportive care guidelines. NCNN website. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#supportive. Updated February 16, 2018. Accessed March 6, 2018.
14. Donohue S, Sesto ME, Hahn DL, et al. Evaluating primary care providers’ views on survivorship care plans generated by an electronic health record system. J Oncol Pract. 2015;11(3):e329-e335.
15. Tevaarwerk AJ, Wisinski KB, Buhr KA, et al. Leveraging electronic health record systems to create and provide electronic cancer survivorship care plans: a pilot study. J Oncol Pract. 2014;10(3):e150-e159.
16. Smith SL, Singh-Carlson S, Downie L, Payeur N, Wai ES. Survivors of breast cancer: patient perspectives on survivorship care planning. J Cancer Surviv. 2011;5(4):337-344.
17. Stricker CT, O’Brien M. Implementing the commission on cancer standards for survivorship care plans. Clin J Oncol Nurs. 2014;18(suppl 1):15-22.
18. Neuman HB, Steffens NM, Jacobson N, et al. Oncologists’ perspectives of their roles and responsibilities during multi-disciplinary breast cancer follow-up. Ann Surg Oncol. 2016;23(3):708-714.
19. Palmer SC, Stricker CT, Panzer SL, et al. Outcomes and satisfaction after delivery of a breast cancer survivorship care plan: Results of a multicenter trial. J Oncol Pract. 2015;11(2):e222-e229.
20. Brennan ME, Gormally JF, Butow P, Boyle FM, Spillane AJ. Survivorship care plans in cancer: a systematic review of care plan outcomes. Br J Cancer. 2014;111(10):1899-1908.
21. Chen RC, Hoffman KE, Sher DJ, et al. Development of a standard survivorship care plan template for radiation oncologists. Pract Radiat Oncol. 2016;6(1):57-65.
22. Seaborne LA, Huenerberg KJ, Bohler A, et al. Developing electronic health record based program to deliver survivorship care plans and visits at the UW breast center. Poster presented at American Society of Clinical Oncology Survivorship Symposium; January 15-16, 2016; San Francisco CA.
23. Collie K, McCormick J, Waller A, et al. Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors. Curr Oncol. 2014;21(1):18-28.
24. Playdon M, Ferrucci LM, McCorkle R, et al. Health information needs and preferences in relation to survivorship care plans of long-term cancer survivors in the American Cancer Society’s study of cancer survivors-I. J Cancer Surviv. 2016;10(4):674-685.
In January 2016 there were an estimated 15.5 million people in the United States who were living with a cancer diagnosis, representing 4.8% of the population. That number is expected to increase to 20.3 million by 2026.1 The 5-year relative survival rate for all cancers diagnosed during 2005 to 2011 was 69%.2 As more individuals with a cancer diagnosis now live longer, cancer survivorship is receiving increased attention. A report from the Institute of Medicine3 identified the essential components of survivorship care, including the provision of a survivorship care plan (SCP) containing specific diagnosis, treatment, and follow-up information (Table 1). To maintain accreditation in their respective organizations, the American College of Surgeons’ Commission on Cancer and the National Accreditation Program for Breast Centers (NAPBC) have included standards on providing treatment summaries and SCPs in person to those patients who have completed cancer treatments given with curative intent.4,5
SCPs are personalized documents presented to cancer patients at the end of treatment that summarize key aspects of cancer treatment and recommend appropriate ongoing medical care and self-management. The purpose of the SCP is both to educate cancer survivors and to create a portable document that can be shared with primary care providers to facilitate coordinated care.6 There are multiple barriers to SCP implementation, which may include the time required to create an SCP, inadequate reimbursement for the time spent creating and delivering the plan, a lack of risk-stratified guidelines for coordinated care, and the incomplete automation of diagnosis and treatment summarization by the electronic health record (EHR).7
Survivorship care in radiation oncology
The American College of Radiology includes the recommendation for regular, ongoing follow-up in the standards for accreditation for radiation oncology practice.8 Radiation oncology practices often provide the initial follow-up appointment about a month after the prescribed radiation treatment has been completed. The twofold purpose of this appointment is to assess the response to treatment and to evaluate acute treatment-related effects.9 The appointment may include a skin evaluation, assessment for any acute treatment effects, informal counseling on maintaining a healthy lifestyle, and recommendations for posttreatment care and follow-up. The appointment may also be an opportune time for delivering the SCP because radiation therapy is often the final treatment modality in active therapy for breast cancer patients.
A review of the literature yields scant data on the incorporation of SCPs into a radiation oncology practice. A 2014 survey of members of the American Society of Radiation Oncology10for a response percentage of 14.7%. Almost all providers follow their patients after treatment (97% (n = 574 respondents/3987 total membership, 14.4% response rate) showed that although most radiation oncologists provide long-term follow-up care to their patients after treatment completion (97%), fewer than half of those surveyed indicated that they delivered SCPs for curative-intent patients (40%), and even fewer delivered for palliative-intent patients (19%). Standards for the American Society for Radiation Oncology’s Accreditation Program for Excellence11 outline content for end-of-treatment documentation. Typically, the documentation includes a detailed treatment summary prepared by the treating radiation oncologist. This treatment summary includes the patient’s diagnosis, the area treated, radiation doses received, number of fractions delivered, therapy start date, therapy completion date, and overall tolerance of treatment in a clinical summary. The treatment summary is communicated to other providers involved in the patient’s care to promote care coordination, but it is not typically provided to patients.
Development of University of Wisconsin survivorship care planning
As an important component of maintaining NAPBC accreditation, the University of Wisconsin (UW) Health Breast Center began the process of formalizing and optimizing SCPs for breast cancer survivors who are followed at the center. Multidisciplinary input from surgical, medical, and radiation oncology was obtained. Representatives from those disciplines met regularly to reach consensus on the treatment summary and SCP content. The following 3 documents were created for use during a transition visit at the end of treatment: the written individualized SCP to be provided to the survivor and his/her primary care providers, a general survivorship patient education booklet, and a patient questionnaire to identify survivors’ concerns and additional resources that may be beneficial.
Treatment summary
Working in collaboration with IT specialists, we enabled out-of-the-box functionality within our EHR. This cancer-specific functionality provides a central and standard location within each survivor’s problem list to systematically document information regarding cancer diagnosis, stage, and treatment associated with a specific cancer diagnosis. Each treating provider (surgeon, medical oncologist, radiation oncologist, genetic counselor, etc) is responsible for entering and updating the relevant components within the treatment summary (ie, the surgeon enters and maintains the surgical details, the medical oncologist does likewise for chemotherapy and other medical therapies, etc). Information is updated and current, creating a dynamic documentation of diagnosis and treatment that can be used in clinic notes, patient after-visit summaries, and SCPs.
Survivorship care plan
This same EHR functionality is leveraged to generate, populate, and maintain the individualized SCP for each breast cancer survivor. The Treatment Summary section of the SCP can be quickly prepared within the EHR by autopopulating data previously entered by treating providers. Content and language for SCP templates in breast, colorectal, prostate, and gynecologic cancers are in use at the time of publication. The templates are developed as a collaborative effort between oncology subspecialists, with input from the UW Health survivor and family advocacy councils.
Each template contains a Treatment Summary section and an SCP section. The Treatment Summary section includes survivor general information, diagnosis and treatment information, and the clinical and supportive/survivor care team names and contact information. The SCP section includes follow-up recommendations, signs of recurrence and/or symptoms to report, healthy lifestyle and maintenance, chronic or late effects of specific treatment if applicable (eg, surgery, chemotherapy by drug, radiation therapy, and endocrine therapy), and general resources for common psychosocial concerns (Table 1).12,13
Each SCP is visible to the entire health care team, including other specialists and primary care, as long as they have access to UW Health’s EHR.14 The result is a readily accessible, comprehensive document that is individualized for each survivor, residing in a standard location with standardized format and content to facilitate review and use.15
General survivorship patient education booklet
Many cancer survivors request additional information about their posttreatment concerns. The “UW Health Facts for You: Cancer Survivorship, Carbone Cancer Center” booklet was developed by a multidisciplinary team including oncologists, advanced practice providers (APPs), navigators, social workers, program leadership, cancer survivors, and caregivers. The guide includes detailed information for the cancer survivor on topics including nutrition, exercise, sleep, tobacco cessation, sexual health, and spirituality. Common concerns and symptom management are addressed as well as a comprehensive list of community resources. The booklet can be found at http://www.uwhealth.org/healthfacts/cancer/7834.
Survivorship questionnaire
Breast cancer survivors often have multiple concerns as they transition from active treatment to the survivorship phase of their cancer journey. Specific concerns may vary slightly form one survivor to another. Guided by recommendations for the American Society of Clinical Oncology and the National Comprehensive Cancer Network, we developed a 10-question, 2-page questionnaire to identify those concerns with input from members of the Breast Cancer Steering Committee. Members of the committee include surgical, medical, and radiation oncologists, AAPs, radiologists, pathologists, program leadership, and nurses, along with breast cancer survivors. Elements in the questionnaire include nutrition, activity, mood, sleep, sexual health, employment/insurance, pain/swelling, desires regarding pregnancy or prevention, memory/concentration, smoking, alcohol, genetic testing/counseling, and assistance with establishing care with a primary care provider. By completing the questionnaire, breast cancer survivors identify specific concerns within each category and are able to request additional information about those concerns and/or a referral to appropriate resources. They may also select the I need nothing further option if the concern is present but already being addressed.
SCP delivery and the transition visit
The next task in implementation of the care process for survivors encompassed the development of clinical workflows and processes to provide the document to the breast cancer survivor at the completion of treatment. In a study of breast cancer survivors, it was found that the preferred format for survivorship care planning is generally an in-person consultation at completion of treatment with an oncology professional.16 The best time for distribution of the written SCP is, however, unclear. Intuitively, it seems optimal to distribute SCPs around the time of completion of active treatment. However, for SCP delivery to be feasible and sustainable, delivery must be integrated into existing clinical care-delivery processes, and content must be streamlined and focused to meet the needs of their intended recipients without becoming overly burdensome to prepare and deliver.17
Ultimately, and after significant multidisciplinary discussion, it was determined that Stage 0-III breast cancer patients would have a visit focusing on symptoms and transitioning to surveillance follow-up (Transition Visit) as they completed active curative-intent cancer treatment. During this Transition Visit, the SCP document would be provided and reviewed with survivors. The Transition Visit for breast cancer survivors would be conducted by an APP following the completion of their final stage of active, primary treatment (surgery, chemotherapy, and/or radiation therapy). Additional long-term adjuvant therapy for breast cancer survivors (ie, trastuzumab, endocrine therapy) would continue as indicated during and after delivery of the SCP.
The radiation oncology clinic was chosen as a venue for these Transition Visits for breast cancer survivors whose treatment included radiotherapy. Despite little historical experience with delivery of SCPs in radiation oncology clinics, this was a logical choice given that radiotherapy is usually the final phase of active treatment for these breast cancer survivors, and a follow-up visit about a month after completing radiotherapy is already part of standard practice. Collaborating with the multidisciplinary UW Health Breast Center, we therefore integrated the formal breast survivorship care planning process and provision of the SCP into the current radiation oncology workflow. About 40% of the roughly 600 breast cancer patients treated by surgical and/or medical oncology at our institution annually also receive radiation therapy at our site. For the remaining 60% of breast cancer survivors who do not receive radiation therapy or who completed radiotherapy at an outside facility, the SCP is provided by an APP within the UW Health Breast Center.
UW radiation oncology survivorship transition visit
The overall workflow of our Transition Visit is depicted in the Figure. Toward the end of the breast cancer survivor’s radiation treatments, the radiation oncologist instructs the schedulers to arrange the 1-month, post-radiation Transition Visit with the APP and informs the survivor about the nature of the appointment. The Transition Visit is scheduled as a 60-minute appointment. Before the survivor’s arrival, an APP generates the written SCP. The activity includes completing the Treatment Summary, or verifying the accuracy of a prepopulated Treatment Summary, and individualizing the SCP section for the patient based on treatment received and follow-up recommendations using drop-down functionality. As the SCP is printed for review with the survivor, it is simultaneously sent to the survivor’s primary care provider. This is accomplished by using EHR functionality to route the document internally to UW primary care providers or automatically faxing the document to external primary care providers. Each SCP is also marked as complete within the EHR for the purposes of documenting compliance with this activity for later data analysis.
On arrival for the appointment, each breast cancer survivor completes the survivorship questionnaire. During the Transition Visit, the questionnaire is reviewed with the survivor and additional information is provided. Referral options are discussed if indicated with desired referrals made by the APP. The survivor is interviewed and examined for any persistent side effects of treatment. Next, the Treatment Summary and SCP are reviewed with the survivor, emphasizing the follow-up plan, signs or symptoms of breast cancer recurrence, and chronic or late treatment-related toxicities. Ample opportunity is provided for the survivor to ask questions and voice concerns.
Follow-up appointments with members of the patient’s care team (ie, medical, surgical, or radiation oncology) as well as necessary breast imaging (ie, mammogram, MRI) are coordinated and scheduled before the survivor leaves the department. A survey of oncologists (medical, surgical, radiation) identified specific cancer-related components of survivorship care that oncologists felt most responsible for as well as opportunities to improve the quality and efficiency of care provided by oncologists.18 At our institution, the breast surgical, medical, and radiation oncologists all generally participate in follow-up care through at least 1 year following completion of active, primary treatment.
Outcomes, quality improvement opportunities, and continued challenges with the process
There is presently a lack of long-term outcome data about the impact of SCPs. As mandates for the provision of SCPs are made, research focusing on whether SCPs result in improved health behaviors and outcomes, reduced burden in care transitions from the oncology setting, and increased cost-effectiveness will be needed.19 The long-term effects of SCPs on psychological, oncologic, and resource outcomes should be evaluated,20 as well as the impact on health behaviors, such as smoking cessation or participation in rehabilitation programs.21
Following the implementation of our Transition Visits in 2015, we conducted a quality improvement review. This review included summation of 69 recent breast cancer questionnaires from Transition Visits with our APPs (Table 2 and Table 3). The most common concerns raised by our breast cancer survivors include desire for weight loss, improving diet, and increasing physical activity. Of note, concerns did not often translate into a desire for more information or referrals.22 Survivors were generally satisfied with the timing of the Transition Visits and generally indicated that the visits were helpful, with self-reported improvements in their understanding of planned follow-up. A Canadian group evaluating breast and head and neck cancer survivors has suggested that SCPs could produce long-term improvements in healthy lifestyle behaviors; however, further research is needed to determine the extent to which SCPs might improve follow-up care over the long term.23
Finally, although efforts to date have been focused on the breast cancer survivor at the completion of treatment, long-term survivors may also benefit from receiving the SCP. A study by the American Cancer Society found that long-term cancer survivors had unmet informational needs, particularly with regard to screening, long-term cancer and treatment effects, and healthy lifestyle behaviors.24 Identifying and subsequently delivering an SCP to eligible long-term survivors is a challenging prospect, which depends on further refinement of EHR-based tracking of the date of diagnosis, cancer stage, and end-of-treatment date.
Summary and recommendations
Survivorship care has been efficiently integrated into our 1-month post-radiation follow-up appointment for breast cancer survivors. By using current resources in the radiation oncology department, the process has provided an effective way to deliver the SCP to breast cancer survivors. Future plans include implementing the process for all patients receiving curative-intent radiation for additional solid tumor survivors. Quality improvement projects will be developed to assess survivor satisfaction and the impact on health behaviors.
Acknowledgments
The authors thank Amy Heath, MS, RTT, for editorial and manuscript preparation assistance.
In January 2016 there were an estimated 15.5 million people in the United States who were living with a cancer diagnosis, representing 4.8% of the population. That number is expected to increase to 20.3 million by 2026.1 The 5-year relative survival rate for all cancers diagnosed during 2005 to 2011 was 69%.2 As more individuals with a cancer diagnosis now live longer, cancer survivorship is receiving increased attention. A report from the Institute of Medicine3 identified the essential components of survivorship care, including the provision of a survivorship care plan (SCP) containing specific diagnosis, treatment, and follow-up information (Table 1). To maintain accreditation in their respective organizations, the American College of Surgeons’ Commission on Cancer and the National Accreditation Program for Breast Centers (NAPBC) have included standards on providing treatment summaries and SCPs in person to those patients who have completed cancer treatments given with curative intent.4,5
SCPs are personalized documents presented to cancer patients at the end of treatment that summarize key aspects of cancer treatment and recommend appropriate ongoing medical care and self-management. The purpose of the SCP is both to educate cancer survivors and to create a portable document that can be shared with primary care providers to facilitate coordinated care.6 There are multiple barriers to SCP implementation, which may include the time required to create an SCP, inadequate reimbursement for the time spent creating and delivering the plan, a lack of risk-stratified guidelines for coordinated care, and the incomplete automation of diagnosis and treatment summarization by the electronic health record (EHR).7
Survivorship care in radiation oncology
The American College of Radiology includes the recommendation for regular, ongoing follow-up in the standards for accreditation for radiation oncology practice.8 Radiation oncology practices often provide the initial follow-up appointment about a month after the prescribed radiation treatment has been completed. The twofold purpose of this appointment is to assess the response to treatment and to evaluate acute treatment-related effects.9 The appointment may include a skin evaluation, assessment for any acute treatment effects, informal counseling on maintaining a healthy lifestyle, and recommendations for posttreatment care and follow-up. The appointment may also be an opportune time for delivering the SCP because radiation therapy is often the final treatment modality in active therapy for breast cancer patients.
A review of the literature yields scant data on the incorporation of SCPs into a radiation oncology practice. A 2014 survey of members of the American Society of Radiation Oncology10for a response percentage of 14.7%. Almost all providers follow their patients after treatment (97% (n = 574 respondents/3987 total membership, 14.4% response rate) showed that although most radiation oncologists provide long-term follow-up care to their patients after treatment completion (97%), fewer than half of those surveyed indicated that they delivered SCPs for curative-intent patients (40%), and even fewer delivered for palliative-intent patients (19%). Standards for the American Society for Radiation Oncology’s Accreditation Program for Excellence11 outline content for end-of-treatment documentation. Typically, the documentation includes a detailed treatment summary prepared by the treating radiation oncologist. This treatment summary includes the patient’s diagnosis, the area treated, radiation doses received, number of fractions delivered, therapy start date, therapy completion date, and overall tolerance of treatment in a clinical summary. The treatment summary is communicated to other providers involved in the patient’s care to promote care coordination, but it is not typically provided to patients.
Development of University of Wisconsin survivorship care planning
As an important component of maintaining NAPBC accreditation, the University of Wisconsin (UW) Health Breast Center began the process of formalizing and optimizing SCPs for breast cancer survivors who are followed at the center. Multidisciplinary input from surgical, medical, and radiation oncology was obtained. Representatives from those disciplines met regularly to reach consensus on the treatment summary and SCP content. The following 3 documents were created for use during a transition visit at the end of treatment: the written individualized SCP to be provided to the survivor and his/her primary care providers, a general survivorship patient education booklet, and a patient questionnaire to identify survivors’ concerns and additional resources that may be beneficial.
Treatment summary
Working in collaboration with IT specialists, we enabled out-of-the-box functionality within our EHR. This cancer-specific functionality provides a central and standard location within each survivor’s problem list to systematically document information regarding cancer diagnosis, stage, and treatment associated with a specific cancer diagnosis. Each treating provider (surgeon, medical oncologist, radiation oncologist, genetic counselor, etc) is responsible for entering and updating the relevant components within the treatment summary (ie, the surgeon enters and maintains the surgical details, the medical oncologist does likewise for chemotherapy and other medical therapies, etc). Information is updated and current, creating a dynamic documentation of diagnosis and treatment that can be used in clinic notes, patient after-visit summaries, and SCPs.
Survivorship care plan
This same EHR functionality is leveraged to generate, populate, and maintain the individualized SCP for each breast cancer survivor. The Treatment Summary section of the SCP can be quickly prepared within the EHR by autopopulating data previously entered by treating providers. Content and language for SCP templates in breast, colorectal, prostate, and gynecologic cancers are in use at the time of publication. The templates are developed as a collaborative effort between oncology subspecialists, with input from the UW Health survivor and family advocacy councils.
Each template contains a Treatment Summary section and an SCP section. The Treatment Summary section includes survivor general information, diagnosis and treatment information, and the clinical and supportive/survivor care team names and contact information. The SCP section includes follow-up recommendations, signs of recurrence and/or symptoms to report, healthy lifestyle and maintenance, chronic or late effects of specific treatment if applicable (eg, surgery, chemotherapy by drug, radiation therapy, and endocrine therapy), and general resources for common psychosocial concerns (Table 1).12,13
Each SCP is visible to the entire health care team, including other specialists and primary care, as long as they have access to UW Health’s EHR.14 The result is a readily accessible, comprehensive document that is individualized for each survivor, residing in a standard location with standardized format and content to facilitate review and use.15
General survivorship patient education booklet
Many cancer survivors request additional information about their posttreatment concerns. The “UW Health Facts for You: Cancer Survivorship, Carbone Cancer Center” booklet was developed by a multidisciplinary team including oncologists, advanced practice providers (APPs), navigators, social workers, program leadership, cancer survivors, and caregivers. The guide includes detailed information for the cancer survivor on topics including nutrition, exercise, sleep, tobacco cessation, sexual health, and spirituality. Common concerns and symptom management are addressed as well as a comprehensive list of community resources. The booklet can be found at http://www.uwhealth.org/healthfacts/cancer/7834.
Survivorship questionnaire
Breast cancer survivors often have multiple concerns as they transition from active treatment to the survivorship phase of their cancer journey. Specific concerns may vary slightly form one survivor to another. Guided by recommendations for the American Society of Clinical Oncology and the National Comprehensive Cancer Network, we developed a 10-question, 2-page questionnaire to identify those concerns with input from members of the Breast Cancer Steering Committee. Members of the committee include surgical, medical, and radiation oncologists, AAPs, radiologists, pathologists, program leadership, and nurses, along with breast cancer survivors. Elements in the questionnaire include nutrition, activity, mood, sleep, sexual health, employment/insurance, pain/swelling, desires regarding pregnancy or prevention, memory/concentration, smoking, alcohol, genetic testing/counseling, and assistance with establishing care with a primary care provider. By completing the questionnaire, breast cancer survivors identify specific concerns within each category and are able to request additional information about those concerns and/or a referral to appropriate resources. They may also select the I need nothing further option if the concern is present but already being addressed.
SCP delivery and the transition visit
The next task in implementation of the care process for survivors encompassed the development of clinical workflows and processes to provide the document to the breast cancer survivor at the completion of treatment. In a study of breast cancer survivors, it was found that the preferred format for survivorship care planning is generally an in-person consultation at completion of treatment with an oncology professional.16 The best time for distribution of the written SCP is, however, unclear. Intuitively, it seems optimal to distribute SCPs around the time of completion of active treatment. However, for SCP delivery to be feasible and sustainable, delivery must be integrated into existing clinical care-delivery processes, and content must be streamlined and focused to meet the needs of their intended recipients without becoming overly burdensome to prepare and deliver.17
Ultimately, and after significant multidisciplinary discussion, it was determined that Stage 0-III breast cancer patients would have a visit focusing on symptoms and transitioning to surveillance follow-up (Transition Visit) as they completed active curative-intent cancer treatment. During this Transition Visit, the SCP document would be provided and reviewed with survivors. The Transition Visit for breast cancer survivors would be conducted by an APP following the completion of their final stage of active, primary treatment (surgery, chemotherapy, and/or radiation therapy). Additional long-term adjuvant therapy for breast cancer survivors (ie, trastuzumab, endocrine therapy) would continue as indicated during and after delivery of the SCP.
The radiation oncology clinic was chosen as a venue for these Transition Visits for breast cancer survivors whose treatment included radiotherapy. Despite little historical experience with delivery of SCPs in radiation oncology clinics, this was a logical choice given that radiotherapy is usually the final phase of active treatment for these breast cancer survivors, and a follow-up visit about a month after completing radiotherapy is already part of standard practice. Collaborating with the multidisciplinary UW Health Breast Center, we therefore integrated the formal breast survivorship care planning process and provision of the SCP into the current radiation oncology workflow. About 40% of the roughly 600 breast cancer patients treated by surgical and/or medical oncology at our institution annually also receive radiation therapy at our site. For the remaining 60% of breast cancer survivors who do not receive radiation therapy or who completed radiotherapy at an outside facility, the SCP is provided by an APP within the UW Health Breast Center.
UW radiation oncology survivorship transition visit
The overall workflow of our Transition Visit is depicted in the Figure. Toward the end of the breast cancer survivor’s radiation treatments, the radiation oncologist instructs the schedulers to arrange the 1-month, post-radiation Transition Visit with the APP and informs the survivor about the nature of the appointment. The Transition Visit is scheduled as a 60-minute appointment. Before the survivor’s arrival, an APP generates the written SCP. The activity includes completing the Treatment Summary, or verifying the accuracy of a prepopulated Treatment Summary, and individualizing the SCP section for the patient based on treatment received and follow-up recommendations using drop-down functionality. As the SCP is printed for review with the survivor, it is simultaneously sent to the survivor’s primary care provider. This is accomplished by using EHR functionality to route the document internally to UW primary care providers or automatically faxing the document to external primary care providers. Each SCP is also marked as complete within the EHR for the purposes of documenting compliance with this activity for later data analysis.
On arrival for the appointment, each breast cancer survivor completes the survivorship questionnaire. During the Transition Visit, the questionnaire is reviewed with the survivor and additional information is provided. Referral options are discussed if indicated with desired referrals made by the APP. The survivor is interviewed and examined for any persistent side effects of treatment. Next, the Treatment Summary and SCP are reviewed with the survivor, emphasizing the follow-up plan, signs or symptoms of breast cancer recurrence, and chronic or late treatment-related toxicities. Ample opportunity is provided for the survivor to ask questions and voice concerns.
Follow-up appointments with members of the patient’s care team (ie, medical, surgical, or radiation oncology) as well as necessary breast imaging (ie, mammogram, MRI) are coordinated and scheduled before the survivor leaves the department. A survey of oncologists (medical, surgical, radiation) identified specific cancer-related components of survivorship care that oncologists felt most responsible for as well as opportunities to improve the quality and efficiency of care provided by oncologists.18 At our institution, the breast surgical, medical, and radiation oncologists all generally participate in follow-up care through at least 1 year following completion of active, primary treatment.
Outcomes, quality improvement opportunities, and continued challenges with the process
There is presently a lack of long-term outcome data about the impact of SCPs. As mandates for the provision of SCPs are made, research focusing on whether SCPs result in improved health behaviors and outcomes, reduced burden in care transitions from the oncology setting, and increased cost-effectiveness will be needed.19 The long-term effects of SCPs on psychological, oncologic, and resource outcomes should be evaluated,20 as well as the impact on health behaviors, such as smoking cessation or participation in rehabilitation programs.21
Following the implementation of our Transition Visits in 2015, we conducted a quality improvement review. This review included summation of 69 recent breast cancer questionnaires from Transition Visits with our APPs (Table 2 and Table 3). The most common concerns raised by our breast cancer survivors include desire for weight loss, improving diet, and increasing physical activity. Of note, concerns did not often translate into a desire for more information or referrals.22 Survivors were generally satisfied with the timing of the Transition Visits and generally indicated that the visits were helpful, with self-reported improvements in their understanding of planned follow-up. A Canadian group evaluating breast and head and neck cancer survivors has suggested that SCPs could produce long-term improvements in healthy lifestyle behaviors; however, further research is needed to determine the extent to which SCPs might improve follow-up care over the long term.23
Finally, although efforts to date have been focused on the breast cancer survivor at the completion of treatment, long-term survivors may also benefit from receiving the SCP. A study by the American Cancer Society found that long-term cancer survivors had unmet informational needs, particularly with regard to screening, long-term cancer and treatment effects, and healthy lifestyle behaviors.24 Identifying and subsequently delivering an SCP to eligible long-term survivors is a challenging prospect, which depends on further refinement of EHR-based tracking of the date of diagnosis, cancer stage, and end-of-treatment date.
Summary and recommendations
Survivorship care has been efficiently integrated into our 1-month post-radiation follow-up appointment for breast cancer survivors. By using current resources in the radiation oncology department, the process has provided an effective way to deliver the SCP to breast cancer survivors. Future plans include implementing the process for all patients receiving curative-intent radiation for additional solid tumor survivors. Quality improvement projects will be developed to assess survivor satisfaction and the impact on health behaviors.
Acknowledgments
The authors thank Amy Heath, MS, RTT, for editorial and manuscript preparation assistance.
1. Statistics. National Cancer Institute, Division of Cancer Control & Population Sciences website. http:///cancercontrol.cancer.gov/ocs/statistics/statistics.html. Updated October 17, 2016. Accessed March 6, 2018.
2. Cancer facts & figures 2016. American Cancer Society website. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html. Published 2016. Accessed February 27, 2018.
3. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academies Press; 2006.
4. Knutson A, McNamara E. Cancer program standards: ensuring patient-centered care. American College of Surgeons website. https://www.facs.org/quality-programs/cancer/coc/standards. Published August 2016. Accessed March 6, 2018.
5. National Accreditation Program for Breast Centers. NAPBC standards manual. American College of Surgeons website. https://www.facs.org/~/media/files/quality%20programs/napbc/2014%20napbc%20standards%20manual.ashx. Published 2014. Accessed March 6, 2018.
6. Salz T, McCabe MS, Onstad EE, et al. Survivorship care plans: is there buy-in from community oncology providers? Cancer. 2014;120(5):722-730.
7. Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK, Wollins DS, Shulman LN. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning. J Oncol Pract. 2014;10(6):345-351.
8. Dobelbower RR, Cotter G, Schilling PJ, Parsai EI, Carroll JM. Radiation oncology practice accreditation. Rays. 2001;26(3):191-198.
9. Hartford AC, Conway PD, Desai NB, et al. ACR-ASTRO practice parameter for communication: radiation oncology. The American College of Radiology website. http://www.acr.org/-/media/ACR/Files/Practice-Parameters/RadOnc.pdf. Updated 2014. Accessed March 6, 2018.
10. Koontz BF, Benda R, De Los Santos J, et al. US radiation oncology practice patterns for posttreatment survivor care. Pract Radiat Oncol. 2016;6(1):50-56.
11. American Society of Therapeutic Radiation Oncologists. APEx program standards. ASTRO website. http://www.astro.org/uploadedFiles/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Published February 1, 2016. Accessed March 6, 2018.
12. Clinical practice survivorship guidelines and adaptations. American Society of Clinical Oncology website. http://www.asco.org/practice-guidelines/cancer-care-initiatives/prevention-survivorship. Published 2013. Accessed March 6, 2018.
13. National Comprehensive Cancer Network. Supportive care guidelines. NCNN website. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#supportive. Updated February 16, 2018. Accessed March 6, 2018.
14. Donohue S, Sesto ME, Hahn DL, et al. Evaluating primary care providers’ views on survivorship care plans generated by an electronic health record system. J Oncol Pract. 2015;11(3):e329-e335.
15. Tevaarwerk AJ, Wisinski KB, Buhr KA, et al. Leveraging electronic health record systems to create and provide electronic cancer survivorship care plans: a pilot study. J Oncol Pract. 2014;10(3):e150-e159.
16. Smith SL, Singh-Carlson S, Downie L, Payeur N, Wai ES. Survivors of breast cancer: patient perspectives on survivorship care planning. J Cancer Surviv. 2011;5(4):337-344.
17. Stricker CT, O’Brien M. Implementing the commission on cancer standards for survivorship care plans. Clin J Oncol Nurs. 2014;18(suppl 1):15-22.
18. Neuman HB, Steffens NM, Jacobson N, et al. Oncologists’ perspectives of their roles and responsibilities during multi-disciplinary breast cancer follow-up. Ann Surg Oncol. 2016;23(3):708-714.
19. Palmer SC, Stricker CT, Panzer SL, et al. Outcomes and satisfaction after delivery of a breast cancer survivorship care plan: Results of a multicenter trial. J Oncol Pract. 2015;11(2):e222-e229.
20. Brennan ME, Gormally JF, Butow P, Boyle FM, Spillane AJ. Survivorship care plans in cancer: a systematic review of care plan outcomes. Br J Cancer. 2014;111(10):1899-1908.
21. Chen RC, Hoffman KE, Sher DJ, et al. Development of a standard survivorship care plan template for radiation oncologists. Pract Radiat Oncol. 2016;6(1):57-65.
22. Seaborne LA, Huenerberg KJ, Bohler A, et al. Developing electronic health record based program to deliver survivorship care plans and visits at the UW breast center. Poster presented at American Society of Clinical Oncology Survivorship Symposium; January 15-16, 2016; San Francisco CA.
23. Collie K, McCormick J, Waller A, et al. Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors. Curr Oncol. 2014;21(1):18-28.
24. Playdon M, Ferrucci LM, McCorkle R, et al. Health information needs and preferences in relation to survivorship care plans of long-term cancer survivors in the American Cancer Society’s study of cancer survivors-I. J Cancer Surviv. 2016;10(4):674-685.
1. Statistics. National Cancer Institute, Division of Cancer Control & Population Sciences website. http:///cancercontrol.cancer.gov/ocs/statistics/statistics.html. Updated October 17, 2016. Accessed March 6, 2018.
2. Cancer facts & figures 2016. American Cancer Society website. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2016.html. Published 2016. Accessed February 27, 2018.
3. Hewitt M, Greenfield S, Stovall E, eds. From cancer patient to cancer survivor: lost in transition. Washington, DC: National Academies Press; 2006.
4. Knutson A, McNamara E. Cancer program standards: ensuring patient-centered care. American College of Surgeons website. https://www.facs.org/quality-programs/cancer/coc/standards. Published August 2016. Accessed March 6, 2018.
5. National Accreditation Program for Breast Centers. NAPBC standards manual. American College of Surgeons website. https://www.facs.org/~/media/files/quality%20programs/napbc/2014%20napbc%20standards%20manual.ashx. Published 2014. Accessed March 6, 2018.
6. Salz T, McCabe MS, Onstad EE, et al. Survivorship care plans: is there buy-in from community oncology providers? Cancer. 2014;120(5):722-730.
7. Mayer DK, Nekhlyudov L, Snyder CF, Merrill JK, Wollins DS, Shulman LN. American Society of Clinical Oncology clinical expert statement on cancer survivorship care planning. J Oncol Pract. 2014;10(6):345-351.
8. Dobelbower RR, Cotter G, Schilling PJ, Parsai EI, Carroll JM. Radiation oncology practice accreditation. Rays. 2001;26(3):191-198.
9. Hartford AC, Conway PD, Desai NB, et al. ACR-ASTRO practice parameter for communication: radiation oncology. The American College of Radiology website. http://www.acr.org/-/media/ACR/Files/Practice-Parameters/RadOnc.pdf. Updated 2014. Accessed March 6, 2018.
10. Koontz BF, Benda R, De Los Santos J, et al. US radiation oncology practice patterns for posttreatment survivor care. Pract Radiat Oncol. 2016;6(1):50-56.
11. American Society of Therapeutic Radiation Oncologists. APEx program standards. ASTRO website. http://www.astro.org/uploadedFiles/_MAIN_SITE/Daily_Practice/Accreditation/Content_Pieces/ProgramStandards.pdf. Published February 1, 2016. Accessed March 6, 2018.
12. Clinical practice survivorship guidelines and adaptations. American Society of Clinical Oncology website. http://www.asco.org/practice-guidelines/cancer-care-initiatives/prevention-survivorship. Published 2013. Accessed March 6, 2018.
13. National Comprehensive Cancer Network. Supportive care guidelines. NCNN website. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#supportive. Updated February 16, 2018. Accessed March 6, 2018.
14. Donohue S, Sesto ME, Hahn DL, et al. Evaluating primary care providers’ views on survivorship care plans generated by an electronic health record system. J Oncol Pract. 2015;11(3):e329-e335.
15. Tevaarwerk AJ, Wisinski KB, Buhr KA, et al. Leveraging electronic health record systems to create and provide electronic cancer survivorship care plans: a pilot study. J Oncol Pract. 2014;10(3):e150-e159.
16. Smith SL, Singh-Carlson S, Downie L, Payeur N, Wai ES. Survivors of breast cancer: patient perspectives on survivorship care planning. J Cancer Surviv. 2011;5(4):337-344.
17. Stricker CT, O’Brien M. Implementing the commission on cancer standards for survivorship care plans. Clin J Oncol Nurs. 2014;18(suppl 1):15-22.
18. Neuman HB, Steffens NM, Jacobson N, et al. Oncologists’ perspectives of their roles and responsibilities during multi-disciplinary breast cancer follow-up. Ann Surg Oncol. 2016;23(3):708-714.
19. Palmer SC, Stricker CT, Panzer SL, et al. Outcomes and satisfaction after delivery of a breast cancer survivorship care plan: Results of a multicenter trial. J Oncol Pract. 2015;11(2):e222-e229.
20. Brennan ME, Gormally JF, Butow P, Boyle FM, Spillane AJ. Survivorship care plans in cancer: a systematic review of care plan outcomes. Br J Cancer. 2014;111(10):1899-1908.
21. Chen RC, Hoffman KE, Sher DJ, et al. Development of a standard survivorship care plan template for radiation oncologists. Pract Radiat Oncol. 2016;6(1):57-65.
22. Seaborne LA, Huenerberg KJ, Bohler A, et al. Developing electronic health record based program to deliver survivorship care plans and visits at the UW breast center. Poster presented at American Society of Clinical Oncology Survivorship Symposium; January 15-16, 2016; San Francisco CA.
23. Collie K, McCormick J, Waller A, et al. Qualitative evaluation of care plans for Canadian breast and head-and-neck cancer survivors. Curr Oncol. 2014;21(1):18-28.
24. Playdon M, Ferrucci LM, McCorkle R, et al. Health information needs and preferences in relation to survivorship care plans of long-term cancer survivors in the American Cancer Society’s study of cancer survivors-I. J Cancer Surviv. 2016;10(4):674-685.
Universal BRCA testing worthwhile for relatives of high-grade serous ovarian cancer patients
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
AUSTIN, TEX. – Universal BRCA mutation testing for first-degree relatives of women with high-grade serous ovarian cancer could prevent significantly more cases, according to a study presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists.
Women with high-grade serous ovarian cancer have a 20% chance of having a BRCA mutation; however, the risk is 50% for first degree relatives of someone with that mutation.
“Until we find an effective screening test for ovarian cancer, which can identify women at an early stage for which there is curative treatment, we need to maximize opportunities for prevention,” said Janice S. Kwon, MD, the gynecologic oncology fellowship program director at the University of British Columbia, Vancouver. “An obvious target group,” she added, are women “at highest risk of developing ovarian cancers, specifically those who inherit mutations in BRCA1 or BRCA2.”
First-degree relatives of ovarian cancer patients have three conceivable options if their BRCA status is unknown, and have no other risk factor for BRCA testing: To not undergo testing; to get tested and, if found to have the mutation, undergo risk-reducing surgery (bilateral salpingo-oophorectomy); or to undergo surgery without testing.
To estimate the efficiency and cost effectiveness of universal BRCA testing of female first-degree relatives of women with high-grade serous ovarian cancer, Dr. Kwon and her colleagues used the “Markov Monte Carlo” simulation model, with a time horizon of 50 years, evaluating the costs and benefits of those three strategies.
They acknowledged that testing excluded women with a personal history of breast cancer and did not include nonhormonal interventions in their analysis.
They found that the average quality-adjusted life year (QUALY) gain of universal BRCA testing was 19.20 years, compared with 18.99 years for no BRCA testing, and 18.48 years for universal surgery with no BRCA testing.
The reason universal surgery was the lowest is because most of these women will be premenopausal at the time of surgery, according to Dr. Kwon. A procedure like a premenopausal oophorectomy has been associated with a 40% increase in all-cause mortality, putting the patient at unnecessary risk, she noted.
Financially, no BRCA testing cost the least, an average of $8,524 Canadian dollars (about US$6,648) followed by universal BRCA at CA$10,103 (about US$7,880) . Universal surgery, with no BRCA testing, cost CA$13,959 (about US$10,888).
Despite the increased cost, the chance to give patients who may be at risk for ovarian cancer a better chance is a good investment, according to Dr. Kwon.
“Any opportunity to prevent ovarian cancer is worthwhile,” Dr. Kwon commented. “If an ovarian cancer patient cannot be tested because she declines testing or, more commonly, because she is deceased, her first-degree relative should have BRCA mutation testing, regardless of other personal or family history or ethnicity.”
She and her coinvestigators reported no relevant financial disclosures.
REPORTING FROM ACOG 2018
Key clinical point: BCRA testing should be extended to all first degree family members of ovarian cancer patients.
Major finding: Quality-adjusted life year gain was higher in patients given universal BRCA testing (an average of 19.20 years) compared with universal surgery (18.48 years) and no BRCA testing (18.99 years).
Study details: A simulation model, was used to evaluate the costs and benefits of three possible approaches for female first-degree relatives of women with high-grade serous ovarian cancer.
Disclosures: The authors had no disclosures.
VIDEO: Office-based hereditary cancer risk testing is doable
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
AUSTIN, TEXAS – , according to Mark S. DeFrancesco, MD, and his associates.
Few community-based ob.gyns. routinely screen their patients for hereditary cancer risks, Dr. DeFrancesco said at the annual meeting of the American College of Obstetricians and Gynecologists, despite ACOG’s position that they are fully trained and qualified to do so. He and his colleagues studied an intervention aimed at streamlining and standardizing genetic assessment in their practice.
A team of physicians, staff, genetic counselors, and process engineers analyzed how hereditary cancer risk assessment was being done at five clinical sites of two community ob.gyn. practices – Dr. DeFrancesco’s practice in Waterbury, Conn., and that of Richard Waldman, MD, in Syracuse, N.Y. – then refined workflows and added tools to create a turnkey process for assessment and screening, Dr. DeFrancesco said.
Under the new process, patients completed a family cancer history in the exam room prior to seeing their physician. Genetic testing was offered to patients who met National Comprehensive Cancer Network (NCCN) guidelines for hereditary/familial high-risk assessment for breast and ovarian cancer (J Natl Compr Canc Netw. 2017 Jan;15[1]:9-20). Those who chose to be tested were able to provide a saliva sample in the office. Counseling was provided to appropriate patients.
The number of patients tested for hereditary risk of breast and ovarian cancer increased dramatically with the new process. During the 8-week period after the intervention, 4% (165) were tested out of 4,107 total patients seen; during the 8 weeks preceding, 1% (43) of 3,882 patients were tested.
Overall, 92.8% (3,811) of patients seen after the intervention provided a family cancer history. Almost a quarter – 23.5% (906) – met NCCN criteria for genetic testing.
A total of 318 patients agreed to undergo genetic testing and 165 (51.9%) completed the process. Nine patients (5.5%) were found to carry a pathogenic gene variant associated with hereditary breast and/or ovarian cancer or Lynch syndrome, Dr. DeFrancesco and colleagues reported.
Patients and providers also were surveyed regarding their experience with the new process. Patients overwhelming noted that they understood the information provided (98.8%), and that they were satisfied with the overall process (97.6%). All 15 providers said that they would continue to use the new process in their practice and most – 13 of 15 – said they found the process thorough and felt comfortable recommending genetic counseling without referral to a genetic counselor (2 were undecided).
“I think that this study really proves the concept that in a community-based practice, we can test our patients,” Dr. DeFrancesco said in an interview.
Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors include employees of Myriad Genetics, some with ownership interests.
SOURCE: DeFrancesco, MS et al. ACOG 2018 3K.
REPORTING FROM ACOG 2018
Key clinical point: Ob.gyns. can successfully integrate hereditary cancer risk testing into their practices.
Major finding: Office-based genetic testing increased from 1% to 4% of patients seen.
Study details: Prospective, single-arm process intervention study screening more than 4,000 women at 5 ob.gyn. practice sites.
Disclosures: Myriad Genetics sponsored the study. Dr. DeFrancesco reported no financial conflicts of interest. His coauthors included employees of Myriad Genetics, some with ownership interests.
Source: DeFrancesco, MS et al. ACOG 2018 poster 3K.
How does oral contraceptive use affect one’s risk of ovarian, endometrial, breast, and colorectal cancers?
EXPERT COMMENTARY
Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.
Details of the study
Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.3 The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.4
Duration of OC use and risk reduction
In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.
There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.
The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.
Study strengths and weaknesses
The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.1 These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.
Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.
According to the study by Michels and colleagues, overall, women using OCs had a decreased risk of ovarian and endometrial cancers and a trend toward a slightly increased risk of breast cancer.3 Based on this and prior estimates, the overall risk of developing any cancer appears to be lower in OC users than in nonusers.5,6
Consider discussing the points below when counseling women on OC use and cancer risk.
Cancer prevention
- OC use was associated with a significantly decreased risk of both ovarian and endometrial cancers. This effect increased with longer duration of use.
- Ovarian cancer risk reduction persisted regardless of smoking status, BMI, alcohol use, or physical activity level.
- The largest reduction in endometrial cancer was seen in current smokers and patients with a BMI greater than 30 kg/m2.
Breast cancer risk
- There was a trend toward a slightly increased risk of breast cancer with OC use of any duration.
- A Danish cohort study showed a significantly higher risk (although still an overall low risk) of breast cancer with HC use (RR, 1.20 [95% CI, 1.14-1.26]).1
- The differences in these 2 results may be related to study design and population characteristic differences.
Overall cancer risk
- The definitive and larger risk reductions in ovarian and endometrial cancer compared with the lesser risk increase in breast cancer suggest a net decrease in developing any cancer for OC users.3,5,6
Risks of pregnancy prevention failure
- OCs are an effective method for preventing unintended pregnancy. Risks of OCs should be weighed against the risks of unintended pregnancy.
- In the United States, the maternal mortality rate (2015) is 26.4 deaths for every 100,000 women.7 The risk of maternal mortality is substantially higher than even the highest published estimates of HC-attributable breast cancer rates (that is, 13 incremental breast cancers for every 100,000 women using HC; 2 incremental breast cancers for every 100,000 women 35 years of age or younger using HC).1
- Unintended pregnancy is a serious maternal-child health problem, and it has substantial health, social, and economic consequences.8-14
- Unintended pregnancies generate a significant economic burden (an estimated $21 billion in direct and indirect costs for the US health care system per year).15 Approximately 42% of unintended pregnancies end in abortion.16
-- Dana M. Scott, MD, and Mark D. Pearlman, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Mørch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard Ø. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228–2239.
- Scott DM, Pearlman MD. Does hormonal contraception increase the risk of breast cancer? OBG Manag. 2018;30(2):16–17.
- Michels KA, Pfeiffer RM, Brinton LA, Trabert B. Modification of the associations between duration of oral contraceptive use and ovarian, endometrial, breast, and colorectal cancers [published online January 18, 2018]. JAMA Oncol. doi:10.1001/jamaoncol.2017.4942.
- Sedgwick P. Hazards and hazard ratios. BMJ. 2012;345:e5980.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193–200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276–2277.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775–1812.
- Brown SS, Eisenberg L, eds. The best intentions: unintended pregnancy and the well-being of children and families. Washington, DC: The National Academies Press; 1995:50–90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281–286.
- Logan C, Holcombe E, Manlove J, Ryan S; The National Campaign to Prevent Teen Pregnancy and Child Trends. The consequences of unintended childbearing. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf?_ga=2.149310646.1402594583.1524236972-1233479770.1524236972&_gac=1.195699992.1524237056. Accessed April 20, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126–127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154–161.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy and infant care: estimates for 2008. Guttmacher Institute. https://www.guttmacher.org/sites/default/files/report_pdf/public-costs-of-up.pdf. Published October 2013. Accessed April 20, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6–15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: national and state estimates for 2010. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Published February 2015. Accessed April 20, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843–852.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: ovarian cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: uterine cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/corp.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: female breast cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/breast.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: colorectal cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/colorect.html. Accessed April 20, 2018.
EXPERT COMMENTARY
Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.
Details of the study
Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.3 The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.4
Duration of OC use and risk reduction
In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.
There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.
The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.
Study strengths and weaknesses
The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.1 These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.
Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.
According to the study by Michels and colleagues, overall, women using OCs had a decreased risk of ovarian and endometrial cancers and a trend toward a slightly increased risk of breast cancer.3 Based on this and prior estimates, the overall risk of developing any cancer appears to be lower in OC users than in nonusers.5,6
Consider discussing the points below when counseling women on OC use and cancer risk.
Cancer prevention
- OC use was associated with a significantly decreased risk of both ovarian and endometrial cancers. This effect increased with longer duration of use.
- Ovarian cancer risk reduction persisted regardless of smoking status, BMI, alcohol use, or physical activity level.
- The largest reduction in endometrial cancer was seen in current smokers and patients with a BMI greater than 30 kg/m2.
Breast cancer risk
- There was a trend toward a slightly increased risk of breast cancer with OC use of any duration.
- A Danish cohort study showed a significantly higher risk (although still an overall low risk) of breast cancer with HC use (RR, 1.20 [95% CI, 1.14-1.26]).1
- The differences in these 2 results may be related to study design and population characteristic differences.
Overall cancer risk
- The definitive and larger risk reductions in ovarian and endometrial cancer compared with the lesser risk increase in breast cancer suggest a net decrease in developing any cancer for OC users.3,5,6
Risks of pregnancy prevention failure
- OCs are an effective method for preventing unintended pregnancy. Risks of OCs should be weighed against the risks of unintended pregnancy.
- In the United States, the maternal mortality rate (2015) is 26.4 deaths for every 100,000 women.7 The risk of maternal mortality is substantially higher than even the highest published estimates of HC-attributable breast cancer rates (that is, 13 incremental breast cancers for every 100,000 women using HC; 2 incremental breast cancers for every 100,000 women 35 years of age or younger using HC).1
- Unintended pregnancy is a serious maternal-child health problem, and it has substantial health, social, and economic consequences.8-14
- Unintended pregnancies generate a significant economic burden (an estimated $21 billion in direct and indirect costs for the US health care system per year).15 Approximately 42% of unintended pregnancies end in abortion.16
-- Dana M. Scott, MD, and Mark D. Pearlman, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
EXPERT COMMENTARY
Hormonal contraception (HC), including OC, is a central component of women’s health care worldwide. In addition to its many potential health benefits (pregnancy prevention, menstrual symptom management), HC use modifies the risk of various cancers. As we discussed in the February 2018 issue of OBG Management, a recent large population-based study in Denmark showed a small but statistically significant increase in breast cancer risk in HC users.1,2 Conversely, HC use has a long recognized protective effect against ovarian and endometrial cancers. These risk relationships may be altered by other modifiable lifestyle characteristics, such as smoking, alcohol use, obesity, and physical activity.
Details of the study
Michels and colleagues evaluated the association between OC use and multiple cancers, stratifying these risks by duration of use and various modifiable lifestyle characteristics.3 The authors used a prospective survey-based cohort (the NIH-AARP Diet and Health Study) linked with state cancer registries to evaluate this relationship in a diverse population of 196,536 women across 6 US states and 2 metropolitan areas. Women were enrolled in 1995–1996 and followed until 2011. Cancer risks were presented as hazard ratios (HR), which indicate the risk of developing a specific cancer type in OC users compared with nonusers. HRs differ from relative risks (RR) and odds ratios because they compare the instantaneous risk difference between the 2 groups, rather than the cumulative risk difference over the entire study period.4
Duration of OC use and risk reduction
In this study population, OC use was associated with a significantly decreased risk of ovarian cancer, and this risk increased with longer duration of use (TABLE). Similarly, long-term OC use was associated with a decreased risk for endometrial cancer. These effects were true across various lifestyle characteristics, including smoking status, alcohol use, body mass index (BMI), and physical activity level.
There was a nonsignificant trend toward increased risk of breast cancer among OC users. The most significant elevation in breast cancer risk was found in long-term users who were current smokers (HR, 1.21 [95% confidence interval (CI), 1.01–1.44]). OC use had a minimal effect on colorectal cancer risk.
The bottom line. US women using OCs were significantly less likely to develop ovarian and endometrial cancers compared with nonusers. This risk reduction increased with longer duration of OC use and was true regardless of lifestyle. Conversely, there was a trend toward a slightly increased risk of developing breast cancer in OC users.
Study strengths and weaknesses
The effect on breast cancer risk is less pronounced than that reported in a recent large, prospective cohort study in Denmark, which reported an RR of developing breast cancer of 1.20 (95% CI, 1.14–1.26) among all current or recent HC users.1 These differing results may be due to the US study population’s increased heterogeneity compared with the Danish cohort; potential recall bias in the US study (not present in the Danish study because pharmacy records were used); the larger size of the Danish study (that is, ability to detect very small effect sizes); and lack of information on OC formulation, recency of use, and parity in the US study.
Nevertheless, the significant protective effect against ovarian and endometrial cancers (reported previously in numerous studies) should be a part of totality of cancer risk when counseling patients on any potential increased risk of breast cancer with OC use.
According to the study by Michels and colleagues, overall, women using OCs had a decreased risk of ovarian and endometrial cancers and a trend toward a slightly increased risk of breast cancer.3 Based on this and prior estimates, the overall risk of developing any cancer appears to be lower in OC users than in nonusers.5,6
Consider discussing the points below when counseling women on OC use and cancer risk.
Cancer prevention
- OC use was associated with a significantly decreased risk of both ovarian and endometrial cancers. This effect increased with longer duration of use.
- Ovarian cancer risk reduction persisted regardless of smoking status, BMI, alcohol use, or physical activity level.
- The largest reduction in endometrial cancer was seen in current smokers and patients with a BMI greater than 30 kg/m2.
Breast cancer risk
- There was a trend toward a slightly increased risk of breast cancer with OC use of any duration.
- A Danish cohort study showed a significantly higher risk (although still an overall low risk) of breast cancer with HC use (RR, 1.20 [95% CI, 1.14-1.26]).1
- The differences in these 2 results may be related to study design and population characteristic differences.
Overall cancer risk
- The definitive and larger risk reductions in ovarian and endometrial cancer compared with the lesser risk increase in breast cancer suggest a net decrease in developing any cancer for OC users.3,5,6
Risks of pregnancy prevention failure
- OCs are an effective method for preventing unintended pregnancy. Risks of OCs should be weighed against the risks of unintended pregnancy.
- In the United States, the maternal mortality rate (2015) is 26.4 deaths for every 100,000 women.7 The risk of maternal mortality is substantially higher than even the highest published estimates of HC-attributable breast cancer rates (that is, 13 incremental breast cancers for every 100,000 women using HC; 2 incremental breast cancers for every 100,000 women 35 years of age or younger using HC).1
- Unintended pregnancy is a serious maternal-child health problem, and it has substantial health, social, and economic consequences.8-14
- Unintended pregnancies generate a significant economic burden (an estimated $21 billion in direct and indirect costs for the US health care system per year).15 Approximately 42% of unintended pregnancies end in abortion.16
-- Dana M. Scott, MD, and Mark D. Pearlman, MD
Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.
- Mørch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard Ø. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228–2239.
- Scott DM, Pearlman MD. Does hormonal contraception increase the risk of breast cancer? OBG Manag. 2018;30(2):16–17.
- Michels KA, Pfeiffer RM, Brinton LA, Trabert B. Modification of the associations between duration of oral contraceptive use and ovarian, endometrial, breast, and colorectal cancers [published online January 18, 2018]. JAMA Oncol. doi:10.1001/jamaoncol.2017.4942.
- Sedgwick P. Hazards and hazard ratios. BMJ. 2012;345:e5980.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193–200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276–2277.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775–1812.
- Brown SS, Eisenberg L, eds. The best intentions: unintended pregnancy and the well-being of children and families. Washington, DC: The National Academies Press; 1995:50–90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281–286.
- Logan C, Holcombe E, Manlove J, Ryan S; The National Campaign to Prevent Teen Pregnancy and Child Trends. The consequences of unintended childbearing. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf?_ga=2.149310646.1402594583.1524236972-1233479770.1524236972&_gac=1.195699992.1524237056. Accessed April 20, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126–127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154–161.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy and infant care: estimates for 2008. Guttmacher Institute. https://www.guttmacher.org/sites/default/files/report_pdf/public-costs-of-up.pdf. Published October 2013. Accessed April 20, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6–15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: national and state estimates for 2010. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Published February 2015. Accessed April 20, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843–852.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: ovarian cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: uterine cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/corp.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: female breast cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/breast.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: colorectal cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/colorect.html. Accessed April 20, 2018.
- Mørch LS, Skovlund CW, Hannaford PC, Iversen L, Fielding S, Lidegaard Ø. Contemporary hormonal contraception and the risk of breast cancer. N Engl J Med. 2017;377(23):2228–2239.
- Scott DM, Pearlman MD. Does hormonal contraception increase the risk of breast cancer? OBG Manag. 2018;30(2):16–17.
- Michels KA, Pfeiffer RM, Brinton LA, Trabert B. Modification of the associations between duration of oral contraceptive use and ovarian, endometrial, breast, and colorectal cancers [published online January 18, 2018]. JAMA Oncol. doi:10.1001/jamaoncol.2017.4942.
- Sedgwick P. Hazards and hazard ratios. BMJ. 2012;345:e5980.
- Bassuk SS, Manson JE. Oral contraceptives and menopausal hormone therapy: relative and attributable risks of cardiovascular disease, cancer, and other health outcomes. Ann Epidemiol. 2015;25(3):193–200.
- Hunter D. Oral contraceptives and the small increased risk of breast cancer. N Engl J Med. 2017;377(23):2276–2277.
- GBD 2015 Maternal Mortality Collaborators. Global, regional, and national levels of maternal mortality, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016;388(10053):1775–1812.
- Brown SS, Eisenberg L, eds. The best intentions: unintended pregnancy and the well-being of children and families. Washington, DC: The National Academies Press; 1995:50–90.
- Klein JD; American Academy of Pediatrics Committee on Adolescence. Adolescent pregnancy: current trends and issues. Pediatrics. 2005;116(1):281–286.
- Logan C, Holcombe E, Manlove J, Ryan S; The National Campaign to Prevent Teen Pregnancy and Child Trends. The consequences of unintended childbearing. https://pdfs.semanticscholar.org/b353/b02ae6cad716a7f64ca48b3edae63544c03e.pdf?_ga=2.149310646.1402594583.1524236972-1233479770.1524236972&_gac=1.195699992.1524237056. Accessed April 20, 2018.
- Finer LB, Sonfield A. The evidence mounts on the benefits of preventing unintended pregnancy. Contraception. 2013;87(2):126–127.
- Trussell J, Henry N, Hassan F, Prezioso A, Law A, Filonenko A. Burden of unintended pregnancy in the United States: potential savings with increased use of long-acting reversible contraception. Contraception. 2013;87(2):154–161.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy and infant care: estimates for 2008. Guttmacher Institute. https://www.guttmacher.org/sites/default/files/report_pdf/public-costs-of-up.pdf. Published October 2013. Accessed April 20, 2018.
- Forrest JD, Singh S. Public-sector savings resulting from expenditures for contraceptive services. Fam Plann Perspect. 1990;22(1):6–15.
- Sonfield A, Kost K. Public costs from unintended pregnancies and the role of public insurance programs in paying for pregnancy-related care: national and state estimates for 2010. Guttmacher Institute. http://www.guttmacher.org/pubs/public-costs-of-UP-2010.pdf. Published February 2015. Accessed April 20, 2018.
- Finer LB, Zolna MR. Declines in unintended pregnancy in the United States, 2008–2011. N Engl J Med. 2016;374(9):843–852.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: ovarian cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/ovary.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: uterine cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/corp.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: female breast cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/breast.html. Accessed April 20, 2018.
- Surveillance, Epidemiology, and End Results Program. Cancer stat facts: colorectal cancer. Bethesda, MD; National Cancer Institute. http://seer.cancer.gov/statfacts/html/colorect.html. Accessed April 20, 2018.
